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510(k) Data Aggregation

    K Number
    K023433
    Device Name
    VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
    Manufacturer
    PHARMACIA DIAGNOSTICS GMBH & CO. KG
    Date Cleared
    2002-11-13

    (29 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PHARMACIA DIAGNOSTICS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varelisa Cardiolipin Antibodies Screen EIA kit is designed for the qualitative determination of antibodies against cardiolivin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).
    Device Description
    The Varelisa Cardiolipin Antibodies Screen is an indirect noncompetitive enzyme immunoassay for the qualitative determination of antibodies against cardiolipin in serum or plasma.
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