BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P000014 · Supplement: S019 · Decision Jan 11, 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
    VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
    PMA Number
    P000014
    Supplement Number
    S019
    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
    January 11, 2010
    Date Received
    September 4, 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 VITROSIMMUNODIAGNOSTIC PRODUCTS ANTI-HBS ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDERTHE TRADE NAMES VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR, AND IS INDICATED FOR:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK:FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS(HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATIONSTATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THELABORATORY' 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 WHOMETIOLOGY IS UNKNOWN.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE QUANTITATIVE IN VITRO DETERMINATION OF TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUMUSING THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK.

    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)