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510(k) Data Aggregation

    K Number
    K081875
    Device Name
    GENTIAN CYSTATIN C IMMUNOASSAY
    Manufacturer
    Date Cleared
    2008-08-20

    (49 days)

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

    GENTIAN AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin c in human serum and plasma. The measurement of cystatin c is used in the diagnosis and treatment of renal diseases. The instruments that can be used with the assay are: The Beckman Coulter™ Synchron® and UniCel® Systems
    Device Description
    The Gentian cystatin C Immunoassay is a particle enhanced turbidimetric immunoassay (PETIA). The immunoparticles are made from activated polystyrene microspheres to which avian anti-human cystatin C antibodies are covalently attached. The immunoparticles and cystatin C form aggregations that change the absorbance signal, depending on the amount of cystatin C present. Measurements obtained by this device are used for the determination of Cystatin C in human serum and plasma. The Gentian cystatin C assay is calibrated with human Cystatin C calibrators. Cystatin C controls are assayed for the verification of the accuracy and precision of the Gentian cystatin C immunoassay.
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    K Number
    K071388
    Device Name
    GENTIAN CYSTATIN C IMMUNOASSAY
    Manufacturer
    Date Cleared
    2007-11-06

    (172 days)

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

    GENTIAN AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin c in human serum and plasma. The measurement of cystatin c is used in the diagnosis and treatment of renal diseases.
    Device Description
    The Gentian cystatin C immunoassay is a particle enhanced turbidimetric immunoassay (PETIA). The immunoparticles are made from activated polystyrene microspheres to which avian anti-human cystatin C antibodies are covalently attached. The immunoparticles and cystatin C form aggregations that change the absorbance signal, depending on the amount of cystatin C present. Measurements obtained by this device are used for the determination of Cystatin C in human serum and plasma. The Gentian C assay is calibrated with human Cystatin C calibrators. Cystatin C controls are assayed for the verification of the accuracy and precision of the Gentian cystatin C immunoassay.
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