BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P010050 · Supplement: S025 · Decision Sep 18, 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
    IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg) Confirmatory Kit
    PMA Number
    P010050
    Supplement Number
    S025
    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
    September 18, 2025
    Date Received
    July 26, 2024
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to relocate processes for critical raw materials to a site previously approved in the submission

    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)