161 results · 9ms · Sources: EU EUDAMED, US FDA

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Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·2 devices

CHORUS HELICOBACTER PYLORI IgA 

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

CHORUS HELICOBACTER PYLORI IgG

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

CHORUS MYCOPLASMA PNEUMONIAE IgG

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

CHORUS MYCOPLASMA PNEUMONIAE IgA

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

CHORUS HERPES SIMPLEX 1+2 IgG  

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

HbA1c

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Instrumentation Laboratory SpA·1 device

CHORUS HERPES SIMPLEX 1 IgG RECOMBINANT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

CHORUS CHIKUNGUNYA IgM

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·1 device

URIC ACID T FL

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Chema Diagnostica Srl·3 devices

HPV Genotyping Kit (18 Types)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Guangzhou KingCreate Biotechnology Co., Ltd.·1 device

MosaiQ® AiPlex CTDplus

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·AliveDx Suisse SA·2 devices

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class D ·Jiangsu Medomics Medical Technology Co.,Ltd.·4 devices

Upright microscope

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Euromex microscopen bv·1 device

Total IgE (CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Maccura Biotechnology Co., Ltd. ·4 devices

iFlash-Total β HCG

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices