BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P210003 · Supplement: S006 · Decision Sep 28, 2023
    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 Next Qualitative assay, Alinity i HBsAg Next Confirmatory assay
    PMA Number
    P210003
    Supplement Number
    S006
    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
    September 28, 2023
    Date Received
    April 3, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Migration of the Abbott ARCHITECT HBsAg Next Qualitative and ARCHITECT HBsAg Next Confirmatory assay (P210003) to the Alinity i system (referred to as the Alinity i analyzer), which will be known as the Alinity i HBsAg Next Qualitative and Alinity i HBsAg Next Confirmatory 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)