104 results · 12ms · Sources: EU EUDAMED, US FDA

HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

Diagnostic Kit for Antibody to Treponema Pallidum (ELISA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgG (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Severe Fever with Thrombocytopenia Syndrome Virus IgM/IgG Antibody  (Colloidal Gold Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Hepatitis E Virus IgM Antibody (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Hepatitis E Virus IgM Antibody (Colloidal Gold Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for EB Virus Capsid Antigen (VCA) IgA Antibody (ELISA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for EB Virus Nuclear Antigen 1 (NA1) IgA Antibody (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for EB Virus Zta Protein IgA Antibody (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Alpha Fetoprotein (ELISA)

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EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

Detection Kit for Carcino-embryonic Antigen (ELISA)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zhongshan Bio-Tech Co., Ltd.·1 device

N-terminal Pro B-type Natriuretic Peptide Quantitative Detection KIT (Chemiluminescent Immunoassay)

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EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Squamous-cell Carcinoma Quantitative Detection KIT (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Creatine Kinase MB Isozyme Calibrator

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Urinary Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Cardiac Markers Plus Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Immunology Multi Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Total Cholesterol Kit (CHOD–PAP Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device