BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Fluorescence Polarization Immunoassay For Cyclosporine

    PMA: P890025 · Supplement: S010 · Decision Feb 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence Polarization Immunoassay For Cyclosporine
    Trade Name
    TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
    PMA Number
    P890025
    Supplement Number
    S010
    Device Class
    FDA Class 2
    Product Code
    MGU
    Generic Name
    Fluorescence polarization immunoassay for cyclosporine
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 1998
    Date Received
    March 3, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx(R)/TDxFLx(R) Cyclosporine Monoclonal Whole Blood Assay, It is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGU Fluorescence Polarization Immunoassay For Cyclosporine