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510(k) Data Aggregation

    K Number
    K950838
    Device Name
    VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
    Manufacturer
    ZYMETX, INC.
    Date Cleared
    1996-06-17

    (479 days)

    Product Code
    GNT
    Regulation Number
    866.3330
    Why did this record match?
    Product Code :

    GNT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViraZyme® Culture Confirmation Screen for Influenza and Parainfluenza is intended for use as a screening test for respiratory viral cultures infected with influenza type A and B and parainfluenza types 1, 2, 3, and 4. This test will screen culture fluids for the presence of these viruses, but it is not indented for the definitive typing of these viruses.
    Device Description
    Influenza and parainfluenza viruses posses surface glycoproteins with neuraminidase activity, that hydrolyze substrates which contain alphaketosidically linked N-acetylneuraminic acid (Neu5Ac). A modified Neu5Ac molecule has been synthesized and coupled to a chromogen to produce the neuraminidase substrate. In the presence of influenza and parainfluenza the chromogenic substrate is then cleaved by the action of viral neuraminidase, releasing a free chromogen. This free chromogen is then precipitated by combining with a diazonium salt to produce a red color. The red precipitate is then concentrated and collected from the solution onto a filter device.
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