BEUDAMED
    9,386 results · 43ms · Sources: EU EUDAMED, US FDA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY

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

    FDA Pre-Market Approval
    FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR ANTI-HBC IGM

    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

    Aachen Resonance Entwicklungsgesellschft für magnetresonanz-kompatible Medizinprodukte mbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    CE6422227

    Certificate
    MDD Annex II (excluding section 4)·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·BSI Group The Netherlands B.V.·849 Basic UDI-DIs

    CVE6422227

    Certificate
    MDD Annex II (excluding section 4)·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    CE642227

    Certificate
    MDD Annex II (excluding section 4)·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·BSI Group The Netherlands B.V.·3 Basic UDI-DIs

    Ce6422227

    Certificate
    MDD Annex II (excluding section 4)·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    CS6422227

    Certificate
    MDD Annex II (excluding section 4)·Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    PoET B19V

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·1 device