BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990038 · Supplement: S004 · Decision Mar 14, 2003
    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
    DIASORIN HBSAG CONFIRMATORY TEST
    PMA Number
    P990038
    Supplement Number
    S004
    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
    March 14, 2003
    Date Received
    October 29, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF A DIASORIN HBSAG CONFIRMATORY REAGENT TO CONFIRM ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES, AND USE OF A DIASORIN CONFIRMATORY REAGENT SPECIFICALLY IN PRENATAL SCREENING TO CONFIRM ALL ETI-MAK-2 PLUS REPEATEDLY REACTIVE SAMPLES IN THE ABSENCE OF OTHER HBV MARKER TESTING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIASORIN HBSAG CONFIRMATORY TEST AND IS INDICATED FOR AN IN VITRO NEUTRALIZATION ASSAY FOR QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA SAMPLES (EDTA, HEPARIN, AND CITRATE) FOUND TO BE REPEATEDLY REACTIVE FOR HBSAG BY ETI-MAK-2 PLUS. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.

    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)