BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P000014 · Supplement: S007 · Decision May 14, 2004
    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-HBS REAGENT PACK AND CALIBRATORS
    PMA Number
    P000014
    Supplement Number
    S007
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 14, 2004
    Date Received
    May 5, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REPLACEMENT OF KEY EQUIPMENT USED IN PERFORMING THE COATED WELL TEST PROCEDURE AND THE ACCEPTANCE CRITERIA ASSOCIATED WITH ITS USE. IN ADDITION, THE COATED WELL SAMPLING PLAN, RANDOMIZATION METHODS FOR SAMPLING, AND TEST ERROR CORRECTION METHODS HAVE BEEN IMPROVED TO FURTHER ENSURE BATCH QUALITY AND REDUCE PRODUCTION WASTE. THE COATED WELL TEST PROCEDURE IS USED TO VERIFY AN ACCEPTABLE LEVEL OF WELL-TO-WELL PRECISION AND OUTLIER-LEVEL INCIDENCE IN THE COATED WELLS MANUFACTURED FOR THE VITROS ANTI-HBS ASSAY.

    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)