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    K Number
    K092399
    Device Name
    ANTI-MUTATED CITRULLINATED VIMENTIN EIA
    Manufacturer
    ORGENTEC DIAGNOSTIKA GMBH
    Date Cleared
    2010-07-01

    (329 days)

    Product Code
    OQZ
    Regulation Number
    866.5775
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    Product Code :

    OQZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anti-MCV® is an indirect solid phase enzyme immunoassay (ELISA) for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis (RA) in conjunction with other laboratory and clinical findings.
    Device Description
    Anti-MCV® is an indirect solid phase enzyme immunoassay (ELISA) for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis (RA) in conjunction with other laboratory and clinical findings.
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