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    K Number
    K122766
    Device Name
    THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
    Manufacturer
    MICROGENICS CORP.
    Date Cleared
    2013-08-20

    (344 days)

    Product Code
    OUF
    Regulation Number
    862.3840
    Why did this record match?
    Product Code :

    OUF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QMS® Everolimus Assay is intended for the quantitative determination of Everolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.
    Device Description
    The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations. R1 Antibody Reagent: <1.0% Anti-Everolimus polyclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. 1 x 22 mL R2 Microparticle Reagent: <0.6% Everolimus-coated microparticles in buffer containing <0.05% sodium azide as preservative. 1 x 8 mL Precipitation Reagent: Precipitating reagent, and <0.09% sodium azide as preservative. 1 x 8 mL The reagents are supplied ready-to-use in liquid form in plastic HDPE bottles, for storage at 2 to 8°C. The reagent set is sufficient for 100 tests.
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    K Number
    K100144
    Device Name
    THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
    Manufacturer
    MICROGENICS CORP.
    Date Cleared
    2011-02-11

    (388 days)

    Product Code
    OUF, DLJ, LAS
    Regulation Number
    862.3840
    Why did this record match?
    Product Code :

    OUF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QMS® Everolimus assay is intended for the quantitative determination of everolimus, the active ingredient of Zortress®, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus Calibrators set is intended for use in calibration of the QMS Everolimus Assay. The QMS® Everolimus Controls set is intended for use in quality control of the QMS® Everolimus Assay.
    Device Description
    The QMS® Everolimus Assay system is a homogeneous assay utilizing particle agglutination technology and competitive binding principles.
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