BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Fluorescence Polarization Immunoassay For Cyclosporine

    PMA: P890025 · Supplement: S014 · Decision Sep 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence Polarization Immunoassay For Cyclosporine
    Trade Name
    TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
    PMA Number
    P890025
    Supplement Number
    S014
    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
    September 5, 2002
    Date Received
    March 18, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.

    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