BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P030026 · Supplement: S016 · Decision Jul 15, 2009
    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
    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR
    PMA Number
    P030026
    Supplement Number
    S016
    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
    July 15, 2009
    Date Received
    February 20, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISION OF THE INTENDED USE TO INCLUDE USE OF THE VITROS 5600INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTICPRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBCCALIBRATOR AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK:FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM)IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (HEPARIN, EDTA AND CITRATE) AND NEONATE SERUMUSING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTICSYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM WHEN USED FOR THE INVITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANTIGEN (ANTI-HBC IGM) INHUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA, HEPARIN OR CITRATE) AND NEONATE SERUM USING VITROS ANTI-HBC IGM REAGENT PACKS.THE VITROS ANTI-HBC IGM CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THEVITROS 5600 INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACKS.

    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)