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    K Number
    K061408
    Device Name
    EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
    Manufacturer
    EUROIMMUN US LLC
    Date Cleared
    2006-10-05

    (136 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EUROIMMUN Endomysium IFA kit is designed for the semi-quantitative and qualitative determination of antibodies against Endomysium (EMA) in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathies associated with celiac disease in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA clearance letter for a medical device (EUROIMMUN Endomysium IFA kit) and primarily discusses its regulatory classification and substantial equivalence to a predicate device. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

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