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510(k) Data Aggregation

    K Number
    K951799
    Device Name
    VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
    Manufacturer
    LIGHT DIAGNOSTICS
    Date Cleared
    1996-03-20

    (336 days)

    Product Code
    GQX
    Regulation Number
    866.3900
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    Product Code :

    GQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Diagnostics Varicella-zoster virus Direct Immunofluorescence Assay is intended for in vitro diagnostic use in the qualitative detection of VZV from vesicular smears and in cell culture viral isolation and confirmation.
    Device Description
    Light Diagnostics Varicella-zoster virus direct Immunofluorescence DFA) uses the standard laboratory direct Assav (VZV immunofluorescence technique for the culture confirmation and direct specimen detection of Varicella-zoster virus. The DFA is based on the principle of antigen identification using a detector monoclonal antibody conjugated to fluorescein isothiocyanate. The substrate consists of a slide prepared from a direct specimen vesicular smear or the tissue cultured cells from a clinical specimen inoculum. Anti VZV FITC labeled antibody is applied to the substrate. The antibody will bind to specific antigen, if present, in the substrate. The fluorescein conjugated monoclonal antibody allows for visualization of the antigen / antibody complex by fluorescence microscopy. A blend of mouse monoclonal antibodies are used as detector antibodies in Light Diagnostics Varicella-zoster virus direct Immunofluorescence Assay. The monoclonal antibodies are specific for the glycoprotein gp I or the immediate early antigen of VZV. The use of monoclonal antibodies ensures increased specificity and reduced non-specific interference.
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