BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010050 · Supplement: S011 · Decision Jun 24, 2011
    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 2000 HBS AG CONFIRMATORY KIT
    PMA Number
    P010050
    Supplement Number
    S011
    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 24, 2011
    Date Received
    September 29, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN AUTOMATED MEANS OF CONFIRMATION TESTING ON-BOARD THE IMMULITE 2000 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG CONFIRMATORY KIT AND IS INDICATED FOR: IMMULITE 2000 HBSAG CONFIRMATORY IS INTENDED FOR IN VITRO DIAGNOSTIC USE WITH IMMULITE 2000 ANALYZERS IN CONJUNCTION WITH THE IMMULITE 2000 HBSAG ASSAY - FOR THE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, HEPARINIZED, CITRATE) THAT WERE REPEATEDLY REACTIVE WHEN TESTED BY THE IMMULITE/ IMMULITE 1000 HBSAG ASSAY OR BY THE IMMULITE 2000 HBSAG 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 Core, Be Antigen, Be Antibody, B Core Igm)