BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    PMA: P110041 · Supplement: S016 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
    Trade Name
    Atellica IM Hepatitis B surface Antigen II (HBsII)
    PMA Number
    P110041
    Supplement Number
    S016
    Device Class
    FDA Class 2
    Product Code
    LOM
    Generic Name
    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
    Regulation Number
    866.3172
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2025
    Date Received
    July 21, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the biotin remediated Atellica IM Hepatitis B surface Antigen II (HBsII) 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 Antigen, B Surface Antigen, Be Antigen)