BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110029 · Supplement: S029 · Decision Jan 7, 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
    Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory
    PMA Number
    P110029
    Supplement Number
    S029
    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
    January 7, 2020
    Date Received
    August 1, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for migration of the ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Calibrators, ARCHITECT HBsAg Qualitative Confirmatory, and ARCHITECT HBsAg Controls onto the Alinity i Analyzer. The device, as modified, will be marketed under the trade names Alinity i HBsAg Qualitative II Reagent Kit, Alinity i HBsAg Qualitative II Calibrators, Alinity i HBsAg Qualitative II Confirmatory Reagent Kit, and Alinity I HBsAg Qualitative II Controls.

    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)