BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P050048 · Supplement: S004 · Decision Apr 25, 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
    BIO-RAD MONOLISA ANTI-HBS EIA
    PMA Number
    P050048
    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
    April 25, 2011
    Date Received
    September 28, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE MONOLISA ANTI-HBS EIA ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM, ADDING LITHIUM HEPARIN AND SODIUM HEPARIN TO THE LIST OF ACCEPTABLE PLASMA SPECIMEN TYPES, A CHANGE IN THE DYE COLOR IN THE CUTOFF CALIBRATOR, REVISION TO THE SPECIMEN STORAGE REQUIREMENTS, AND MODIFICATION OF THE STORAGE INSTRUCTIONS FOR THE WORKING CONJUGATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MONOLISA ANTI-HBS EIA AND IS INDICATED FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA, HEPARIN, OR CITRATED PLASMA. THE ASSAY RESULTS MAY BE USED AS AN AIDE IN THE DETERMINATION OF SUSCEPTIBILITY OF HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE MONOLISA ANTI-HBS EIA IS INTENDED FOR MANUAL USE AND WITH THE BIO-RAD EVOLIS AUTOMATED MICROPLATE SYSTEM IN THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN.

    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)