BEUDAMED
    5,228 results · 38ms · Sources: EU EUDAMED, US FDA

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AXSYM AUSAB

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS ANTI-HBE ASSAY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys HBeAg

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys HBcAg

    CMV Cytomegalovirus Antibody IgM Rapid Test Kit(Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

    CMV Cytomegalovirus Antibody IgM/IgG Rapid Test (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

    TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

    Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Dengue (NS1 Ag+IgG/IgM) DUO Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

    Anti-E monoclonal, human IgM clones: MS-258, 906

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

    Anti-C monoclonal, human IgM clones: MS-24, P3X25513G8

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

    Anti-K (KEL1) monoclonal, human IgM clone: MS-56

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

    Anti-AB monoclonal, IgM clones: ES-15, ES-4

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·ANTITOXIN GmbH·1 device

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device