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510(k) Data Aggregation

    K Number
    DEN100020
    Device Name
    DENV DETECT IGM CAPTURE ELISA
    Manufacturer
    INBIOS INTL., INC.
    Date Cleared
    2011-04-08

    (170 days)

    Product Code
    OSU
    Regulation Number
    866.3945
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    Product Code :

    OSU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DENV Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to DEN recombinant antigens (DENRA) in serum for the presumptive clinical laboratory diagnosis of Dengue virus infection. The assay is intended for use only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease.
    Device Description
    The DENV Detect™ IgM Capture ELISA is a sandwich-type immunoassay. The test kit includes microtiter wells coated with anti-human IgM antibodies, DEN IgM Negative, and IgM Positive controls, DENV Sample Dilution Buffer, Dengue-derived recombinant antigens (DENRA) and normal cell antigens (NCA). The test kit also contains a HRPlabeled DEN-specific monoclonal antibody and tetramethylbenzidine (TMB) substrate which are used to detect DEN IgM antibodies in the wells.
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