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510(k) Data Aggregation

    K Number
    K973910
    Device Name
    GLIADIN ANTIBODIES ELISA
    Manufacturer
    GENESIS DIAGNOSTICS LTD.
    Date Cleared
    1999-02-17

    (491 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENESIS DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The gliadin antibodies enzyme immunoassay system is used for the detection and semiquantitative measurement of (IgG and IgA) antibodies to wheat gliadin in human serum. The test results obtained with the test kit are used as an aid in the diagnosis of gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis in children and adult patients.
    Device Description
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