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510(k) Data Aggregation

    K Number
    K984126
    Device Name
    THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    Date Cleared
    1999-01-11

    (54 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    MCD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This test system is designed for the manual or automated, qualitative detection of IqG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use,
    Device Description
    Not Found
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