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510(k) Data Aggregation

    K Number
    K962028
    Device Name
    WELLCOLEX E-COLI OI57 ZC60
    Manufacturer
    MUREX DIAGNOSTICS, INC.
    Date Cleared
    1996-11-01

    (162 days)

    Product Code
    GNA
    Regulation Number
    866.3255
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUREX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954920
    Device Name
    MUREX RUB-EX
    Manufacturer
    MUREX DIAGNOSTICS, INC.
    Date Cleared
    1996-08-21

    (300 days)

    Product Code
    LQN
    Regulation Number
    866.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUREX DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.
    Device Description
    The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum. The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hosag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected.
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