BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Enzyme Immunoassay, Tracrolimus

    PMA: P970007 · Decision Aug 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Enzyme Immunoassay, Tracrolimus
    Trade Name
    IMX TACROLIMUS II ASSAY
    PMA Number
    P970007
    Device Class
    FDA Class 2
    Product Code
    MLM
    Generic Name
    ENZYME IMMUNOASSAY, TRACROLIMUS
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    August 26, 1997
    Date Received
    February 18, 1997
    Expedited Review
    Y
    Docket Number
    97M-0520

    Advisory Committee Statement

    Approval for the IMx(R) Tacrolimus II Assay. This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy.

    Classifications

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

    Product Code Device Name
    MLM Enzyme Immunoassay, Tracrolimus