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    K Number
    K100499
    Device Name
    ORGENTEC RHEUMATOID FACTOR EIA
    Manufacturer
    ORGENTEC DIAGNOSTIKA GMBH
    Date Cleared
    2010-10-27

    (247 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGENTEC DIAGNOSTIKA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGENTEC DIAGNOSTIKA GMBH

    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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    K Number
    K030929
    Device Name
    ANA DETECT
    Manufacturer
    ORGENTEC DIAGNOSTIKA GMBH
    Date Cleared
    2003-05-02

    (39 days)

    Product Code
    LJM, LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGENTEC DIAGNOSTIKA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORGENTEC ANA Detect assay is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-A-La, Sm, SmRNP, Scl-70, Jo-1, and centromeric antigens.
    Device Description
    Not Found
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