BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010050 · Supplement: S008 · Decision Jun 2, 2009
    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
    IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY
    PMA Number
    P010050
    Supplement Number
    S008
    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
    June 2, 2009
    Date Received
    May 13, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE PRODUCT LABELING TO INCLUDE A ¿HOT ZONE CUTOFF¿ UNDER THE INTERPRETATION OF RESULTS SECTION. THIS ¿HOT ZONE CUTOFF¿ ESTABLISHES A LEVEL AT WHICH HIGH HBSAG REACTIVE SAMPLES MAY BE REPORTED AS REACTIVE WITHOUT CONFIRMATORY TESTING.

    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)