BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P060034 · Supplement: S004 · Decision Aug 2, 2010
    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
    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
    August 2, 2010
    Date Received
    September 25, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANDING THE INTENDED USE TO INCLUDE USE WITH THE EVOLISAUTOMATED MICROPLATE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMEMONOLISA ANTI-HBC IGM EIA AND IS INDICATED FOR USE IN THE QUALITATIVE DETECTION OF IGMANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUMEDTA, 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. THE MONOLISA ANTI-HBC IGM IS INTENDED FORMANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OFIGM ANTIBODIES TO HEPATITIS B VIRUS.

    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)