BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P010051 · Supplement: S023 · Decision Aug 4, 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 Systems Total Antibodies to Hepatitis B Core Antigen (Anti-HBc)
    PMA Number
    P010051
    Supplement Number
    S023
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 4, 2025
    Date Received
    July 16, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an internal site to internal site transfer of a manufacturing process

    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)