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    K Number
    K022017
    Device Name
    RHIGENE MESACUP-2 TEST RNP, MODEL M7741
    Manufacturer
    RHIGENE, INC.
    Date Cleared
    2002-08-14

    (55 days)

    Product Code
    LKO
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RHIGENE MESACUP-2 TEST RNP, MODEL M7741

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

    The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

    Device Description

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    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document discusses regulatory approval for a medical device (RhiGene MESACUP-2 Test RNP) and its intended use, but it does not include specifics about the acceptance criteria, the study design, sample sizes, or expert qualifications for performance evaluation.

    Therefore, many of the requested fields cannot be filled based on the given text.

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