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    K Number
    K974552
    Device Name
    DIAMEDIX IS-MEASLES IGG TEST SYSTEM
    Manufacturer
    DIAMEDIX CORP.
    Date Cleared
    1998-01-28

    (55 days)

    Product Code
    LJB
    Regulation Number
    866.3520
    Why did this record match?
    Product Code :

    LJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diamedix Is-Measles IgG test system is an Enzyme Immunoassay (EIA) for the semi-quantitative detection of IgG antibodies in human serum to measles virus as an aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals, and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
    Device Description
    The Is-Measles IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Measles (rubeola) antigen in human serum
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    K Number
    K971620
    Device Name
    QUANTA LITE RUBEOLA (MEASLES) IGG
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-07-22

    (82 days)

    Product Code
    LJB
    Regulation Number
    866.3520
    Why did this record match?
    Product Code :

    LJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.
    Device Description
    Not Found
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