LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020694
    Device Name
    QAB2A IGM ELISA KIT
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-04-19

    (46 days)

    Product Code
    MVS
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    MVS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QAB2A IgM Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgM isotype autoantibody to ß2-Glycoprotein-1 in human serum. The presence of ß2-GP1 antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1