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510(k) Data Aggregation

    K Number
    K984596
    Device Name
    VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
    Manufacturer
    ZYMETX, INC.
    Date Cleared
    1999-03-04

    (66 days)

    Product Code
    GNR
    Regulation Number
    866.3330
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    Product Code :

    GNR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViraSTAT® FITC-Labeled Anti-Influenza test panel is intended for the qualitative detection and confirmation of influenza A and B virus isolates from infected cell cultures through the use of the ViraSTAT® FITC-Labeled Anti-Influenza Pool and the identification and confirmation of influenza A and B by typing with separate ViraSTAT® FITC-Labeled Anti-Influenza type A or B, monoclonal antibodies, respectively. Performance characteristics have not been established for direct specimen staining.
    Device Description
    The ViraSTAT® FITC-Labeled Anti-Influenza A and B monoclonal antibodies are fluorescently-labeled antibodies for use in culture confirmation of influenza A and B infections, respectively, in standard cell culture. The virus to be detected is grown in the appropriate cell culture system, fixed on a slide or coverslip and then the cell preparation is stained with the fluorescently-labeled monoclonal antibody. The stained sample is then viewed under a fluorescent microscope for a positive or negative identification. A positive sample is determined when cells displaying typical apple-green fluorescence are observed. Fluorescence may be present in the nucleus alone, in the nucleus and the cytoplasm, or in the cytoplasm alone. A negative sample is determined when slide wells or coverslips show no specific apple-green fluorescence in the cells and have at least 50 intact red counterstaining cells per well or 50% of the monolayer remaining on the coverslips or slides that are counterstained red.
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