BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060034 · Decision May 31, 2007
    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
    BIO RAD MONOLISA ANTI-HBC IGM EIA
    PMA Number
    P060034
    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
    May 31, 2007
    Date Received
    November 22, 2006
    Expedited Review
    N
    Docket Number
    07M-0254

    Advisory Committee Statement

    APPROVAL FOR THE BIO-RAD MONOLISA ANTI-HBC IGM EIA. THE DEVICE IS INDICATED FOR: THE BIO-RAD MONOLISA ANTI-HBC IGM EIA IS AN ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM CITRATE, ACD [ACID CITRATE DEXTROSE], LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION.

    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)