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    K Number
    K111452
    Device Name
    PRESAGE ST2 ASSAY
    Manufacturer
    CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
    Date Cleared
    2011-12-09

    (198 days)

    Product Code
    OYG, JJX
    Regulation Number
    862.1117
    Why did this record match?
    Product Code :

    OYG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The Presage® ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.
    Device Description
    The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format.
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