BEUDAMED
    8,763 results · 42ms · 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 ANTI-HBC IGM REAGENT PAK/CALIBRATOR

    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

    DGM-0549

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

    DGM-459

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·2 Basic UDI-DIs

    DGM-458

    Certificate
    IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

    DGM-549

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·31 Basic UDI-DIs

    DGM-548

    Certificate
    IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·33 Basic UDI-DIs

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag HOME TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    iSTATIS COVID-19 Ag TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI COVID ANTIBODY TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

    INSTI HIV ANTIBODY SELF-TEST

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

    INSTI HCV CONTROL TEST KIT

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device