BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110041 · Supplement: S015 · Decision Mar 4, 2025
    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
    ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay
    PMA Number
    P110041
    Supplement Number
    S015
    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
    March 4, 2025
    Date Received
    September 13, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for migration of the ADVIA Centaur HBsAg II (HBsII) and the ADVIA Centaur HBsAg Confirmatory (Conf) Assay, and the HBsAg II Quality Control (HBsII QC) onto the Atellica CI analyzer, which will be known as the Atellica IM HBsAg II (HBsII) and Atellica IM HBsAg II Confirmatory (HBsII Conf) Assay.

    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)