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    K Number
    K041657
    Device Name
    THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
    Manufacturer
    THERMO ELECTRON CORPORATION
    Date Cleared
    2004-08-30

    (73 days)

    Product Code
    KQN, JIS, JJX
    Regulation Number
    862.1090
    Why did this record match?
    Product Code :

    KQN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen. 2. The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only. 3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
    Device Description
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