BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160019 · Supplement: S010 · Decision Feb 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
    PMA Number
    P160019
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 27, 2020
    Date Received
    September 3, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for (1) the inclusion of a biotin scavenger antibody in Reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for Elecsys HBsAg II and Elecsys HBsAg Confirmatory Test.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)