91 results · 17ms · Sources: EU EUDAMED, US FDA

RIDA®UNITY EHEC/EPEC

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·1 device

RIDA®GENE EHEC/EPEC

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·R-Biopharm AG·3 devices

Human Epididymal Protein 4(CLIA) 、HE-4 Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

TOTAL PROSTATIC SPECIFIC ANTIGEN

Device
EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·On the market·1 country

TOTAL PROSTATIC SPECIFIC ANTIGEN

Device
EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·On the market·1 country

TOTAL PROSTATIC SPECIFIC ANTIGEN

Device
EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·On the market·1 country

TOTAL PROSTATIC SPECIFIC ANTIGEN

Device
EU IVDR · Eu Ivd Class C ·Chemclin Diagnostics Co., Ltd.·On the market·1 country

High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

α-fetoprotein test (Up-converting Phosphor Technology)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Cancer Antigen 125 test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Cardiac Troponin-I test (Up-converting Phosphor Technology)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

N-terminal Pro-B-type Natriuretic Peptide test (Up-converting Phosphor Technology)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Procalcitonin test (Up-converting Phosphor Technology)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

C reactive protein test (Up-converting Phosphor Technology)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries

Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)

Device
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries