BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Fluorescence Polarization Immunoassay For Cyclosporine

    PMA: P890025 · Supplement: S012 · Decision Sep 29, 1999
    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/MONOCLONAL WHOLE BLOOD
    PMA Number
    P890025
    Supplement Number
    S012
    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 29, 1999
    Date Received
    September 23, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding "Caution: This product contains natural dry rubber" to the labeling.

    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