BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P110029 · Supplement: S042 · Decision Oct 11, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
    PMA Number
    P110029
    Supplement Number
    S042
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 11, 2023
    Date Received
    May 8, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the formulation change for the common accessories Pre-Trigger and Trigger, and storage condition changes for Pre-Trigger, used on ARCHITECT i2000SR, ARCHITECT i1000SR and Alinity i analyzer.