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    K Number
    K242585
    Device Name
    Cystatin C
    Manufacturer
    Sentinel CH. S.p.A.
    Date Cleared
    2025-05-16

    (259 days)

    Product Code
    NDY
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sentinel CH. S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system. Measurement of cystatin C aids in the diagnosis and treatment of renal diseases. For laboratory professional use only.
    Device Description
    The Cystatin C assay is an automated clinical chemistry assay. Cystatin C is a particle-enhanced turbidimetric immunoassay (PETIA) developed to accurately and reproducibly measure cystatin C levels in serum and plasma. Latex particles coated with anti-human cystatin C antibody agglutinate when mixed with sample containing human cystatin C. The change in absorbance due to agglutination of the reaction mixture is proportional to the quantity of human cystatin C in the sample.
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