QbD RepS BV

MetaOptima Technology Inc.

Manufacturer

🇨🇦 Canada·1 Importer

Genomic Health Inc.

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·5 Devices

Foundation Medicine, Inc.

Manufacturer

🇺🇸 United States·1 Importer

Natera, Inc.

Manufacturer

🇺🇸 United States

INCELLDX, INC

Manufacturer

🇺🇸 United States

Coyote Bioscience Co., Ltd.

Manufacturer

🇨🇳 China

QuantuMDx Group Ltd

Manufacturer

1 Importer

Autobio Biochemistry Co.,Ltd

Manufacturer

🇨🇳 China

Shanghai Kehua Bio-engineering Co., Ltd.

Manufacturer

🇨🇳 China·122 Basic UDI-DIs·122 Devices

Zybio Inc.

Manufacturer

🇨🇳 China·147 Basic UDI-DIs·212 Devices·3 Importers

23andMe, Inc.

Manufacturer

🇺🇸 United States·6 Basic UDI-DIs·6 Devices

Guangzhou Decheng Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·1 Device·2 Importers

biped robotics SA

Manufacturer

🇨🇭 Switzerland

Precision for Medicine, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·2 Importers

CamNtech Ltd

Manufacturer

2 Basic UDI-DIs·5 Devices·2 Importers

Pall International SARL

Manufacturer

🇨🇭 Switzerland·1 Importer

Specific Diagnostics

Manufacturer

🇺🇸 United States·1 Importer

MeMed Diagnostics Ltd.

Manufacturer

🇮🇱 Israel·4 Basic UDI-DIs·4 Devices·1 Importer

Xiamen Wiz Biotech Co., Ltd.

Manufacturer

🇨🇳 China·4 Basic UDI-DIs·4 Devices·1 Importer

Shenzhen Superbio Technology Co.,Ltd.

Manufacturer

🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Inpeco SA

Manufacturer

🇨🇭 Switzerland·3 Basic UDI-DIs·7 Devices·1 Importer

Sanway Gene Tech. Inc.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Omega Bio-tek

Manufacturer

🇺🇸 United States

Invenio Imaging Inc.

Manufacturer

🇺🇸 United States

Nanomix, Inc.

Manufacturer

🇺🇸 United States

Nucleix

Manufacturer

🇮🇱 Israel

PRIMA Lab SA

Manufacturer

🇨🇭 Switzerland·2 Importers

GenomeMe Lab Inc.

Manufacturer

🇨🇦 Canada·2 Importers

Hertility Health

Manufacturer

PeopleBio, Inc.

Manufacturer

🇰🇷 South Korea

Golden Helix Inc.

Manufacturer

🇺🇸 United States

AGAPPE DIAGNOSTICS SWITZERLAND GmbH

Manufacturer

🇨🇭 Switzerland

BioFire Diagnostics, LLC

Manufacturer

🇺🇸 United States·1 Importer

GDL Korea Co.,Ltd.

Manufacturer

🇰🇷 South Korea

ProciseDx Inc.

Manufacturer

🇺🇸 United States·3 Basic UDI-DIs·4 Devices

ManukaMed Limited Partnership

Manufacturer

🇳🇿 New Zealand

Hemosonics LLC

Manufacturer

🇺🇸 United States

CareDx Pty Ltd

Manufacturer

🇦🇺 Australia

CoNextions Inc

Manufacturer

🇺🇸 United States

MDT Int'l SA

Manufacturer

🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.

Commonwealth Diagnostics International, Inc.

Manufacturer

🇺🇸 United States

NanoHelix Co., Ltd.

Manufacturer

🇰🇷 South Korea

Avicenna

Manufacturer

🇦🇪 United Arab Emirates·2 Basic UDI-DIs·2 Devices

Exact Sciences Corporation

Manufacturer

🇺🇸 United States

Distalmotion Ltd

Manufacturer

🇨🇭 Switzerland·2 Importers·SGS Belgium NV

Asymptote Ltd.

Manufacturer

Gulden Ophthalmics

Manufacturer

🇺🇸 United States·2 Importers

Atomo Diagnostics Limited

Manufacturer

🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

Xiamen United Medical Instruments Co., Ltd.

Manufacturer

🇨🇳 China·3 Basic UDI-DIs·8 Devices

BPR Medical Limited

Manufacturer

44 Basic UDI-DIs·44 Devices·3 Importers·SGS Belgium NV

Zhengzhou Bioyuan Biotech Co. Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·19 Devices

Pockit diagnostics Ltd

Manufacturer

Guangzhou HEAS BioTech Co., Ltd.

Manufacturer

🇨🇳 China

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

Manufacturer

🇯🇵 Japan·7 Basic UDI-DIs·7 Devices·1 Importer

Shenzhen Tisenc Medical Devices Co., Ltd.

Manufacturer

🇨🇳 China·1 Importer

OraSure Technologies, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·3 Devices

Autobio Diagnostics Co., Ltd.

Manufacturer

🇨🇳 China·129 Basic UDI-DIs·286 Devices·4 Importers

Maine Molecular Quality Controls, Inc.

Manufacturer

🇺🇸 United States·1 Importer

Implicit Care LLC

Manufacturer

🇺🇸 United States·1 Importer

Alife Health Inc.

Manufacturer

🇺🇸 United States

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Manufacturer

🇨🇳 China

Healgen Life Science，LLC

Manufacturer

🇺🇸 United States

Agappe Diagnostics Ltd

Manufacturer

🇮🇳 India

Maternal Newborn Health Innovations Singapore Pte Ltd

Manufacturer

🇸🇬 Singapore

Infrascan, inc.

Manufacturer

🇺🇸 United States·1 Importer

Molbio Diagnostics Limited

Manufacturer

🇮🇳 India·4 Basic UDI-DIs·4 Devices·1 Importer

PredictImmune Ltd.

Manufacturer

Cleveland Diagnostics, Inc.

Manufacturer

🇺🇸 United States

DNA Genotek Inc.

Manufacturer

🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers

Oculox Technologies SA

Manufacturer

🇨🇭 Switzerland

Guangzhou Wondfo Biotech Co., Ltd.

Manufacturer

🇨🇳 China·10 Importers

Yelatma Instrument-Making Enterprise Joint-Stock Company

Manufacturer

🇷🇺 Russian Federation·9 Basic UDI-DIs·20 Devices·TÜV NORD CERT GmbH

Healgen Scientific Limited Liability Company

Manufacturer

🇺🇸 United States·3 Importers

DMETEC Co., LTD.

Manufacturer

🇰🇷 South Korea·1 Importer

Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

InTec PRODUCTS, INC.

Manufacturer

🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

bioLytical Laboratories Inc.

Manufacturer

🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

Amoy Diagnostics Co., LTD.

Manufacturer

🇨🇳 China·57 Basic UDI-DIs·57 Devices·1 Importer

Wrig Nanosystems Private Limited

Manufacturer

🇮🇳 India

Swiss Biotech Innovation SA

Manufacturer

🇨🇭 Switzerland

ARUP Laboratories Inc

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device

NIKOMED USA INC

Manufacturer

🇺🇸 United States

Biosafe S.A.

Manufacturer

🇨🇭 Switzerland·1 Importer

Merlin Biomedical (Xiamen) Co., Ltd.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

Xiamen Innodx Biotech Co., Ltd.

Manufacturer

🇨🇳 China

Xukang Medical Technology (Suzhou) Co., Ltd.

Manufacturer

🇨🇳 China·14 Basic UDI-DIs·32 Devices

Oncotype® Sample Prep Kit

Device

EU IVDR · Eu Ivd Class A ·Genomic Health Inc.·On the market

Oncotype® Sample Prep Kit

Device

EU IVDR · Eu Ivd Class A ·Genomic Health Inc.·On the market

Oncotype DX Breast Recurrence Score® Computational Software

Device

EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·On the market·31 countries

Oncotype DX Breast Recurrence Score® Kit

Device

EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·On the market·31 countries

Oncotype DX Breast Recurrence Score® Kit

Device

EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·On the market·31 countries

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

AMYLASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

APOLIPOPROTEIN B

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

APOLIPOPROTEIN A I

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LACTATE DEHYDROGENASE L ( LDH - L --> P )

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CREATINE KINASE - MB ACTIVITY (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PHOSPHATE INORGANIC / PHOSPHORUS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BILE ACIDS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CHOLINESTERASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

THYROXINE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CYFRA 21-1

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

NEURON SPECIFIC ENOLASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

THYROGLOBULIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

C-PEPTIDE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

INSULIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

INTERLEUKIN 6 (IL-6)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PROCALCITONIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PROGESTERONE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ESTRADIOL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PROLACTIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HUMAN EPIDIDYMIS PROTEIN 4

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

SQUAMOUS CELL CARCINOMA ANTIGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

FOLLICLE STIMULATING HORMONE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LH - RT & POC

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

FERRITIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CANCER ANTIGEN 19-9

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CANCER ANTIGEN 15-3

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CANCER ANTIGEN 125

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CARCINOEMBRYONIC ANTIGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ALPHAFETOPROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

THYROGLOBULIN AUTOANTIBODY

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

FREE THYROXINE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

FREE TRIIODOTHYRONINE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TRIIODOTHYRONINE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

THYROID-STIMULATING HORMONE - RT & POC

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BILIRUBIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CALIBRATORS SINGLE COMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CARDIAC MARKER CONTROLS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CONTROLS FOR RHEUMATOLOGY

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LIPID CONTROLS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYME CONTROLS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CALIBRATORS MULTICOMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ASSAYED MULTICOMPONENT CONTROLS (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ASSAYED MULTICOMPONENT CONTROLS (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CALIBRATORS MULTICOMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

25-HYDROXYVITAMIN D

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HEART-TYPE FATTY ACID BINDING PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

MAGNESIUM

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ANTI-CYCLIC CITRULLINATED PEPTIDE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

A1-MICROGLOBULIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

SUBSTRATES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

MYOGLOBIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LIPASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

NON ESTERIFIED FATTY ACIDS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

LIPOPROTEIN ( A )

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

APOLIPOPROTEIN E SUB-TYPING

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ISCHEMIA MODIFIED ALBUMIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ANGIOTENSIN CONVERTING ENZYME (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HOMOCYSTEINE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HYDROXYBUTYRATE DEHYDROGENASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CREATINE KINASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CARBON DIOXIDE - ELECTRODES (BG)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PHOSPHATE INORGANIC / PHOSPHORUS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CALCIUM

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ANTI-STREPTOLYSIN O (QUANTITATIVE)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

RHEUMATOID FACTORS

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

IMMUNOGLOBULIN M

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

IMMUNOGLOBULIN G

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

IMMUNOGLOBULIN A

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HIGH-SENSITIVITY C-.REACTIVE PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

COMPLEMENT COMPONENT C4

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

COMPLEMENT COMPONENT C3/C3C

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

RETINOL BINDING PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

N-ACETYL-B, D-GLUCOSAMINIDASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BETA2-MICROGLOBULIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HYDROXYBUTYRATE DEHYDROGENASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ALBUMIN (IC) INCL. UALBUMIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CYSTATIN C

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

5'-NUCLEOTIDASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

PRE-ALBUMIN / TRANSTHYRETIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ALKALINE PHOSPHATASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

IMMUNOCHEMISTRY REAGENTS - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TRANSFERRIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TUMOUR MARKERS - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TRIGLYCERIDES

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CHOLESTEROL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

HIGH DENSITY LIPOPROTEIN CHOLESTEROL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

URIC ACID

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

GLUCOSE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

GLUCOSE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

CREATININE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

UREA/BLOOD UREA NITROGEN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

TOTAL PROTEIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BILIRUBIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

GAMMA GLUTAMYLTRANSFERASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BILIRUBIN

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ASPARTATE AMINO-TRANSFERASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ALANINE AMINO-TRANSFERASE

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

AMYLASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

ALBUMIN (CC)

Device

EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries

BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

25-HYDROXYVITAMIN D

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

VITAMIN B12

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

INTERLEUKIN 6 (IL-6)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·Not intended for eu market

Hematology Analyzer

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·1 country

OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Zybio

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Quantitative Real-time PCR System

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Quantitative Real-time PCR System

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Quantitative Real-time PCR System

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Quantitative Real-time PCR System

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

TRANSFERRIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

NON ESTERIFIED FATTY ACIDS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

COMPLEMENT COMPONENT C1Q

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

APOLIPOPROTEIN E SUB-TYPING

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

TROPONIN I/T

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PROCALCITONIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

FIBRINOGEN ASSAYS (FACTOR I)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·0 countries

SUBSTRATES - OTHER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

SPECIFIC PROTEINS - OTHER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ENZYMES - OTHER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

MYOGLOBIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

LIPASE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

MAGNESIUM

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

TOTAL PROTEIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

HIGH DENSITY LIPOPROTEIN CHOLESTEROL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

BILIRUBIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

BILIRUBIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ALANINE AMINO-TRANSFERASE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ASPARTATE AMINO-TRANSFERASE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URIC ACID

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

LACTATE DEHYDROGENASE L ( LDH - L --> P )

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CHOLESTEROL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

GLUCOSE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

TRIGLYCERIDES

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

GASTRIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CREATININE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

RHEUMATOID FACTORS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

IMMUNOGLOBULIN E - TOTAL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

HYDROXYBUTYRATE DEHYDROGENASE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

AMYLASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

BILE ACIDS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

ALBUMIN (IC) INCL. UALBUMIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

LIPOPROTEIN ( A )

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

LACTATE DEHYDROGENASE ISOENZYMES

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

PHOSPHATE INORGANIC / PHOSPHORUS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

IMMUNOGLOBULIN M

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

IMMUNOGLOBULIN G

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

IMMUNOGLOBULIN A

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

HOMOCYSTEINE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

HIGH-SENSITIVITY C-.REACTIVE PROTEIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

FERRITIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CYSTATIN C

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

CALIBRATORS SINGLE COMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CALIBRATORS SINGLE COMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CREATINE KINASE - TOTAL

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

CALIBRATORS SINGLE COMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

COMPLEMENT COMPONENT C4

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

D-DIMER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

COMPLEMENT COMPONENT C3/C3C

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

APOLIPOPROTEIN B

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

CANCER ANTIGEN 125

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CALIBRATORS SINGLE COMPONENT (CC)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

APOLIPOPROTEIN A I

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

ANTI-STREPTOLYSIN O (QUANTITATIVE)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ANTI-STREPTOLYSIN O (QUANTITATIVE)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

THYROGLOBULIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URINE CONTROLS

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PRE-ALBUMIN / TRANSTHYRETIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

FERRITIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

NEURON SPECIFIC ENOLASE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PRE-ALBUMIN / TRANSTHYRETIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

D-DIMER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

CYFRA 21-1

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

D-DIMER

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

HUMAN EPIDIDYMIS PROTEIN 4

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CANCER ANTIGEN 15-3

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

SQUAMOUS CELL CARCINOMA ANTIGEN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CANCER ANTIGEN 242

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CANCER ANTIGEN 72-4

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CANCER ANTIGEN 50

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ANTI-MÛLLERIAN HORMONE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·No longer on the market

C-PEPTIDE

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CANCER ANTIGEN 19-9

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

INSULIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CARCINOEMBRYONIC ANTIGEN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

GASTRIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

ALPHAFETOPROTEIN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

PEPSINOGEN

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market

CALCIUM

Device

EU IVDD · Eu Ivd General ·Zybio Inc.·On the market·32 countries

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·Not intended for eu market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·Not intended for eu market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

SPECIFIC PROTEIN STANDARDS AND CALIBRATORS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

SPECIFIC PROTEIN STANDARDS AND CALIBRATORS

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

C-REACTIVE PROTEIN

Device

EU IVDR · Eu Ivd Class C ·Zybio Inc.·On the market·32 countries

HAEMATOLOGY REAGENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

HAEMATOLOGY REAGENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

Z3

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·1 country

Z3 CRP

Device

EU IVDR · Eu Ivd Class B ·Zybio Inc.·On the market·1 country

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·1 country

MULTIPLE PARAMETERS URINE TESTING - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

MULTIPLE PARAMETERS URINE TESTING - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

MULTIPLE PARAMETERS URINE TESTING - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

MULTIPLE PARAMETERS URINE TESTING - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

EXR 120

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Fluorescence Immunochromatography Analyzer

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

MICROBIOLOGY TESTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

Nucleic Acid Extraction Kit (Magnetic Bead Method)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Device

EU IVDR · Eu Ivd Class A ·Zybio Inc.·On the market·32 countries

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·No longer on the market

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·No longer on the market

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·No longer on the market

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·No longer on the market

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·On the market·5 countries

23andMe Personal Genome Service

Device

EU IVDD · Eu Ivd General ·23andMe, Inc.·No longer on the market·5 countries

Immunofluorescence Analyzer

Device

EU IVDR · Eu Ivd Class A ·Guangzhou Decheng Biotechnology Co., Ltd.·On the market

BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

Device

EU IVDR · Eu Ivd Class A ·Precision for Medicine, Inc.·On the market·6 countries

MotionWatch 8

Device

EU MDR · Eu Md Class 1 ·CamNtech Ltd·On the market

MotionWatch R

Device

EU MDR · Eu Md Class 1 ·CamNtech Ltd·On the market

MotionWatch R

Device

EU MDR · Eu Md Class 1 ·CamNtech Ltd·On the market

PRO-Diary V

Device

EU MDR · Eu Md Class 1 ·CamNtech Ltd·On the market

PRO-Diary Motion

Device

EU MDR · Eu Md Class 1 ·CamNtech Ltd·On the market·1 country

MeMed BV® External Control

Device

EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed BV® Calibrator

Device

EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed BV®

Device

EU IVDR · Eu Ivd Class B ·MeMed Diagnostics Ltd.·On the market·4 countries

MeMed Key®

Device

EU IVDR · Eu Ivd Class A ·MeMed Diagnostics Ltd.·On the market·0 countries

VIROLOGY - RT & POC - OTHER

Device

EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

VIROLOGY - RT & POC - OTHER

Device

EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

INFLUENZA A AND /OR B - RT & POC

Device

EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Device

EU IVDD · Eu Ivd General ·Xiamen Wiz Biotech Co., Ltd.·On the market

HPIV Antigen Rapid Test (Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus (MPxV) Antigen Quality Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus (MPxV) Antigen Quality Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S100-β Rapid Quantitative Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Vitamin B12 (VB12) Rapid Quantitative Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Folic Acid (FA) Rapid Quantitative Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Swab (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Gamma-Hydroxybutyric Acid (GHB) Test Dip Card 10 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Lysergic acid diethylamide (LSD) Test Dip Card 10 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HPIV Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Morphine (MOP)/ Methamphetamine (MET)/ Ketamine (KET) Multi Drug Test Kit

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Morphine (MOP) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Methamphetamine (MET) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Marijuana (THC) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Ketamine (KET) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair Benzoylecgonine (BE) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Hair 3,4-Methylenedioxymethamphetamine (MDMA) Test Kit (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Adenovims (ADV) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Oral Fluid Multi-Drug Test Cup Plus (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Immunofluorescence Analyzer

Device

EU IVDR · Eu Ivd Class A ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Immunofluorescence Analyzer

Device

EU IVDR · Eu Ivd Class A ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Immunofluorescence Analyzer

Device

EU IVDR · Eu Ivd Class A ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

β-HCG Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

β-HCG Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TT4 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TT4 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TT3 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TT3 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TSH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TSH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

tPAIC Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

tPAIC Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TM Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TM Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Testo Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Testo Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TAT Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TAT Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ST2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ST2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

SAA Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

SAA Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S100-β Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S100-β Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Prog Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Prog Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

S-Trust Multi-Drug Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PRL Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PRL Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PIC Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PIC Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PGⅡ Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PGⅡ Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PGⅠ Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PGⅠ Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Lp-PLA2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Lp-PLA2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

LH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

LH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

hs-cTnT Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

H-FABP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

H-FABP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HCY Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HCY Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

hs-cTnT Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FT4 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FT4 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FT3 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FT3 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FSH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FSH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA hs-cTnT Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FT4 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FSH Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FA Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA E2 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CRP Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FT3 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA BNP Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Cortisol Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FT3 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FSH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FA Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FDP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CRP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA E2 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Cortisol Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA BNP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Anti-TPO Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Anti-Tg Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA 25-OH-VD Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

BNP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Neutralizing Antibody Detection Kit (Fluorescence Immunochromatography)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for InFluA/InFluB Ag (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for β2-microglobulin (β2-MG) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for TES (Testosterone) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Sex hormone-binding globulin (SHBG) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Parathyroid Hormone (PTH) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Neutrophil gelatinase-associated lipocalin (NGAL)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Microalbumin (MAU) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Cystatin C (CySC) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Carcinoembryonic Antigen (CEA) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Calcitonin (CT) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

β2-MG Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TES Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

SHBG Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PTH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CysC Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

cTnl/ Myo/ CK-MB Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CT Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

NGAL Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

MAU Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CEA Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AFP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Synthetic marijuana (K2) Test Dip Card 50 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup XR (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FDP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FDP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FA Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FA Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

E2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

E2 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CRP Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CRP Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Cortisol Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Cortisol Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Synthetic marijuana (K2) Test Dip Card 25(Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup SE (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

BNP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

BNP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Anti-TPO Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Anti-TPO Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Anti-Tg Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Anti-Tg Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

VB12 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

VB12 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Tg Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Tg Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

P-TAU-181 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

P-TAU-181 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

W0102069013

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PCT Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

NT-proBNP Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

NT-proBNP Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

MYO Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

MYO Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

INS Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

INS Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

IL-6 Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

IL-6 Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Cup PLUS (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Carisoprodol (SOMA) Test Dip Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/P. V Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

hs-cTnI Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

hs-cTnI Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HbA1c Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FERR Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HbA1c Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FERR Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

D-Dimer Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

D-Dimer Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Monkeypox Virus（MPxV）Antigen Rapid Detection Kit （Immunochromatography Assay）

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

COVID-19 Ag&Influenza A/B Combo Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

COVID-19 Ag&Influenza A/B&RSV Ag Combo Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Adenovims (ADV) Antigen Rapid Test (Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Saliva Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device

EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

cTnI Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

cTnI Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

C-P Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

C-P Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CK-MB Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CK-MB Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CEA Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CEA Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Aβ1-42 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Aβ1-42 Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AMH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AMH Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AFP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AFP Assay kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

25-OH-VD Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

25-OH-VD Assay Kit CLIA

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Progesterone (PROG) Rapid Quantitative Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Multi-Drug Test Card (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Marijuana Test Dip Card 40 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Marijuana Test Dip Card 20 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Fentanyl (FTY) Test Dip Card 20 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA AFP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA C-P Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA IL-6 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA D-Dimer Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CK-MB Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FERR Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA HbA1c Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA FERR Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Cardiac Troponin T (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for BNP (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for C-reactive Protein /Serum Amyloid A (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Estradiol (E2) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Interleukin-6(IL-6)(Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Procalcitonin/Interleukin-6 (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Serum Amyloid A(SAA) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA AFP Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA D-Dimer Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PRL Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PCT/IL-6 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FERR Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

E2 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

fT4 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

fT3 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

FSH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

HbA1c Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

IL-6 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Myo Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

LH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

NT-proBNP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PCT Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

PROG Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

SAA Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

T3 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

T4 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

TSH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

β-HCG Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Progesterone (PROG) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Myoglobin (Myo) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for PRL (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Ferritin(FERR)(Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Free T4 (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Free T3 (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for FSH(Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Luteinizing Hormone (LH) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for HbA1c (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for T4 (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for T3 (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for TSH (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for NT-proBNP (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for β-HCG (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Procalcitonin (PCT) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for 25-HydroxyvitaminD (25-OH-VD) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for D-Dimer/Cardiac Troponin I /Pro-brain natriuretic peptide to amino-terminal

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

D-Dimer Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

cTnT Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Cardiac Troponin I (cTnI) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

cTnI Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

D-Dimer/ cTnI/ NT-proBNP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA hs-cTnI Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for cTnI/Myo/CK-MB (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for C-reactive Protein (hsCRP&CRP) (Time-resolved Fluorescence Immunochromatographic assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CRP/SAA Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CRP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Cortisol Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Anti-Müllerian Hormone (AMH) (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

AMH Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

25-OH-VD Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA 25-OH-VD Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for 2019-Novel Coronavirus(2019-nCoV) Ag Test (Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Diagnostic Kit for Cortisol (Time-resolved Fluorescence Immunochromatographic Assay)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CEA Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA hs-cTnT Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA hs-cTnI Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CK-MB Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA INS Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA MYO Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA MYO Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA NT-proBNP Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CK-MB Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA NT-proBNP Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA CEA Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA PCT Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA PCT Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA P-TAU-181 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Aβ1-42 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA Tg Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA HbA1c Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA VB12 Calibrator

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CLIA VB12 Control

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

Portable Incubator

Device

EU IVDR · Eu Ivd Class A ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ProTube

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·On the market·3 countries

FlexPath Blox

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·No longer on the market

FlexPath Blox

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·On the market

FlexLab

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·On the market·4 countries

Aptio® Automation

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·On the market·14 countries

Accelerator a3600

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·No longer on the market·2 countries

FlexLab X

Device

EU IVDR · Eu Ivd Class A ·Inpeco SA·On the market·7 countries

HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

ProciseDx Analyzer

Device

EU IVDR · Eu Ivd Class A ·ProciseDx Inc.·On the market·10 countries

Procise Stool Collection Kit

Device

EU IVDR · Eu Ivd Class A ·ProciseDx Inc.·On the market·10 countries

Procise Stool Collection Kit

Device

EU IVDR · Eu Ivd Class A ·ProciseDx Inc.·On the market·10 countries

ProciseDx Calibration Cartridge

Device

EU IVDR · Eu Ivd Class A ·ProciseDx Inc.·On the market·10 countries

TRUD

Device

EU MDD · Eu Md Class 2a ·MDT Int'l SA·On the market·4 countries

GAF

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·2 countries

TendoVis

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·10 countries

SportVis

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·1 country

DualVis

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·1 country

RenehaVis

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·10 countries

SportVis

Device

EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·10 countries

AviChem Midi

Device

EU IVDR · Eu Ivd Class A ·Avicenna·Not intended for eu market

AviChem Mini

Device

EU IVDR · Eu Ivd Class A ·Avicenna·Not intended for eu market

Simplitude ByMe

Device

EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

Simplitude ByMe

Device

EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IVD INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device

EU IVDR · Eu Ivd Class A ·Xiamen United Medical Instruments Co., Ltd.·Not intended for eu market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medcial

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·32 countries

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·29 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·29 countries

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·On the market·29 countries

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2b ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

BPR Medical

Device

EU MDD · Eu Md Class 2a ·BPR Medical Limited·No longer on the market

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Endocrine Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Endocrine Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Endocrine Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Tumor Marker Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Zhengzhou Bioyuan Biotech Co. Ltd.·On the market·1 country

CALIBRATION PLASMA FOR HAEMOSTASIS

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·2 countries

CALIBRATION PLASMA FOR HAEMOSTASIS

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·2 countries

COAGULATION FACTOR XIII

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·2 countries

AUTO-IMMUNE DISEASE TESTS - OTHER

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·14 countries

AUTO-IMMUNE DISEASE TESTS - OTHER

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·14 countries

AUTO-IMMUNE DISEASE TESTS - OTHER

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·14 countries

AUTO-IMMUNE DISEASE TESTS - OTHER

Device

EU IVDR · Eu Ivd Class B ·MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.·On the market·14 countries

Intercept i2

Device

EU IVDR · Eu Ivd Class A ·OraSure Technologies, Inc.·On the market·19 countries

Intercept i2

Device

EU IVDR · Eu Ivd Class A ·OraSure Technologies, Inc.·On the market·18 countries

Intercept i2

Device

EU IVDR · Eu Ivd Class A ·OraSure Technologies, Inc.·On the market·19 countries

FSH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Testosterone CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PRL CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

LH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PRG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Sputum Processing Reagent

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Sputum Processing Reagent

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Sputum Processing Reagent

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Anaerobic culture bottle SN

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Anaerobic culture bottle SN

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Aerobic culture bottle SA

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Aerobic culture bottle SA

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

AutoLumo HE4 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HE4 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA50 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA50 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo S100 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

S100 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo HER-2/neu CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HER-2/neu CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo ProGRP Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

ProGRP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo G-17 Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

G-17 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Pepsinogen Ⅱ Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Pepsinogen Ⅱ CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Pepsinogen Ⅰ Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Pepsinogen Ⅰ CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CYFRA 21-1 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CYFRA 21-1 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Anti-CL IgA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-CL IgM Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-CL IgG Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-TG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-TG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-TG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-CL Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CL CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

rT3 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

rT3 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-β2-GP1 IgM Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-β2-GP1 IgG Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-β2-GP1 IgA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-β2-GP1 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-β2-GP1 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Sample Release Reagent

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo β-CTX Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

β-CTX CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo PINP Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PINP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo B19 IgM Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

B19 IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Anti-sp100 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-sp100 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-sp100 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Inflammation Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Endocrine Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Endocrine Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Endocrine Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Cardiac Markers Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Autoimmune Maker Control I

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Autoimmune Maker Control I

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Autoimmune Maker Control I

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Thyroid Speciality Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Thyroid Speciality Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Thyroid Speciality Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMH Control

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgM Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgM Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgM Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgM Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgG Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgG Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgG Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ToRCH IgG Control

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Tumour Marker Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Tumour Marker Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Tumour Marker Control II

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo HS-cTnT Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HS-cTnT CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo H-FABP Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

H-FABP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo NT-proBNP Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

NT-proBNP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CK-MB Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CK-MB CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Anti-gp210 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-gp210 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-gp210 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMA-M2 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMA-M2 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo AMA-M2 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-GBM IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-GBM IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-GBM IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-MPO IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-MPO IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-MPO IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-PR3 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-PR3 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-PR3 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-Ribosomal P IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Ribosomal P IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Ribosomal P IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-nRNP/Sm IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-nRNP/Sm IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-nRNP/Sm IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-Sm IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Sm IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Sm IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Jo-1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

W0102152211

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Jo-1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-Scl-70 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Scl-70 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Scl-70 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-SS-B IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-SS-B IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-SS-B IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Ro-52 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-Ro-52 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-Ro-52 IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Anti-SS-A/Ro IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-SS-A/Ro IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Anti-SS-A/Ro IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo B19 IgG Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

B19 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Mycobacterial Culture Bottle

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo PIVKA-II CLIA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo PIVKA-II CLIA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PIVKA-II CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PIVKA-II CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA242 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA242 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA242 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA242 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA72-4 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA72-4 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA72-4 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA72-4 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA19-9 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA19-9 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA19-9 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA19-9 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA15-3 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo CA15-3 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA15-3 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo SCCA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo SCCA Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

SCCA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

SCCA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Diluent Universal

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market·1 country

System Wash

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Chemiluminescent Substrate

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Chemiluminescent Substrate

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Toxo IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Toxo IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CMV IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CMV IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-1 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-1 IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-2 IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

HSV-2 IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Anti-dsDNA IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-dsDNA IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-dsDNA IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

TRAb CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

TRAb CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

cTnI CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Mycoplasma IES Plus

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

BNP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Mycoplasma TIES

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

hs-CRP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Mycoplasma IES

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Rubella IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CEA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CEA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AFP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AFP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Ferritin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Ferritin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

β2-Microglobulin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

β2-Microglobulin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Rubella IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

CA125 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Anti-CCP IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-CCP IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-CCP IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

SHBG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

17α-OHP CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

DHEA-S CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

NSE CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

NSE CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

fPSA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

tPSA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo E2 Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

E2 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

MYO CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo AMH Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AMH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo C-Peptide Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

C-Peptide CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo Insulin Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

Insulin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo IL-6 Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

IL-6 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

AutoLumo PCT Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

PCT CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

ACTH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

ACTH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo Calcitonin Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Calcitonin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo 25-OH Vitamin D Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

25-OH Vitamin D CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Osteocalcin Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Osteocalcin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo PTH Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

PTH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo TG Calibrators

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

TG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo Anti-TPO Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

Anti-TPO CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo ANA IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

ANA IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

ANA IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo RF IgA Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgA CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo RF IgG Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgG CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo RF Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

AutoLumo RF IgM Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

RF IgM CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

IGF-1 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

IGF-1 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Renin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Renin CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

HGH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

HGH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Cortisol CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Cortisol CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Aerobic Culture Bottle PF

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Anaerobic Culture Bottle FN

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Aerobic Culture Bottle FA

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

AutoLumo T4 Calibrators

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

T4 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·1 country

T4 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

T3 CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

TSH CLIA Microparticles

Device

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

Wash Buffer

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Device

EU IVDR · Eu Ivd Class A ·Autobio Diagnostics Co., Ltd.·On the market

Trueprep® AUTO v2

Device

EU IVDR · Eu Ivd Class A ·Molbio Diagnostics Limited·On the market·1 country

Truelab® Quattro

Device

EU IVDR · Eu Ivd Class A ·Molbio Diagnostics Limited·On the market

Truelab® Duo

Device

EU IVDR · Eu Ivd Class A ·Molbio Diagnostics Limited·On the market

Truelab® Uno Dx

Device

EU IVDR · Eu Ivd Class A ·Molbio Diagnostics Limited·On the market·1 country

Colli-Pee® UAS® FV-5040

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® UCM® FV-5003b

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® UCM® FV-5004

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® UCM® FV-5010

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® UCM® FV-5020

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® FV-5040

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® FV-5004

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® FV-5020c

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® FV-5010

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

Colli-Pee® FV-5020

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·5 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

OMNIgene GUT

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

OMNIgene ORAL

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

OMNIgene ORAL

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene Dx

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

ORAgene DNA

Device

EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·On the market·32 countries

OG-AC1

Device

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·On the market

ORAcollect RNA

Device

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·On the market·32 countries

ORAcollect Dx

Device

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·On the market·32 countries

ORAcollect DNA

Device

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·On the market·32 countries

ORAcollect Dx

Device

EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·On the market·32 countries

ALMAG ACTIVE

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

ALMAG-02

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

MAVIT

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EASYTON

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

ALMAG

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

Magofon

Device

EU MDD · Eu Md Class 2a ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

KDHT-01-"ELAT"

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10-02-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-3-02-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10D-02-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-1-02-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10-01-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10D-01-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-5-01-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-3-01-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-1-01-2

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10D-02

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EDPO-10D-01

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EKpDH-0,1-01-"ELAT"

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

EKaDH-0,1/01-"ELAT"

Device

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·On the market·32 countries

fPSA Rapid Test

Device

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

PSA Rapid Test

Device

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

CancerCheck® PSA

Device

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

CancerCheck ® fPSA

Device

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market

Colloidal Gold Reader

Device

EU IVDR · Eu Ivd Class A ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·Not intended for eu market

Rapid Anti-TB (Mycobacterium Tuberculosis) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

Rapid Anti-TB (Mycobacterium Tuberculosis) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

One Step Dengue NS1 Ag Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

Rapid Rota-Adenovirus Combo Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

ONE STEP Myoglobin/CK-MB-cTnI Combo TEST

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

ONE STEP Troponin I Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

Rapid FOB Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

Rapid FOB Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

ONE STEP H. pylori Ag Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

ONE STEP H. pylori Ag Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·On the market

ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test

Device

EU IVDD · Eu Ivd General ·InTec PRODUCTS, INC.·No longer on the market

HIV MULTIPLE ANTIBODY

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

HIV MULTIPLE ANTIBODY

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

HCV ANTIBODY (TOTAL)

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

HCV ANTIBODY (TOTAL)

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

HCV ANTIBODY (TOTAL)

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·No longer on the market

HIV MULTIPLE ANTIBODY

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

HIV MULTIPLE ANTIBODY

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

HCV ANTIBODY (TOTAL)

Device

EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·On the market

INSTI HIV Self Test

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

iSTATIS COVID-19 Ag HOME TEST

Device

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

iSTATIS COVID-19 Ag HOME TEST

Device

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

iSTATIS COVID-19 Ag TEST

Device

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI COVID ANTIBODY TEST

Device

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV CONTROL TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HCV ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV ANTIBODY SELF-TEST

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 Control Test

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI Multiplex Test Kit

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

INSTI HIV-1/HIV-2 Antibody Test

Device

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

OTHER HPV - NA REAGENTS

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

K-RAS

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

K-RAS

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

K-RAS

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

K-RAS

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

BRCA 1+2

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES

Device

EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·On the market

DEVICES FOR SAMPLES TRANSPORT - OTHER

Device

EU IVDR · Eu Ivd Class A ·ARUP Laboratories Inc·On the market·4 countries

SARS-CoV-2 Antigen Rapid Test Cassette

Device

EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

Single Cell/Low Input RNA Sample Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Adapters Kit（MGI）

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Adapters Kit（MGI）

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Sample Preservation Buffer

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Sample Preservation Buffer

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Pre-amplification Buffer Kit(MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

Pre-amplification Buffer Kit (MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

NGS Universal Dual Index Kit(MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

NGS Universal Dual Index Kit(MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

NGS Universal Dual Index Kit (MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

NGS Universal Dual Index Kit (MGI)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·32 countries

NGS Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Micro RNA Sample Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

DNA Fragmentation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion Torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion Torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion Torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Ion Torrent)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Illumina)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Illumina)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Illumina)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

NGS Universal Index Kit (Illumina)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

Universal Library Preparation Kit

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries

ChromInst™ Universal Library Normalization Kit (Illumina)

Device

EU IVDR · Eu Ivd Class A ·Xukang Medical Technology (Suzhou) Co., Ltd.·On the market·31 countries