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510(k) Data Aggregation

    K Number
    K070206
    Device Name
    DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Date Cleared
    2007-08-30

    (220 days)

    Product Code
    GQW, GOW, GQX
    Regulation Number
    866.3900
    Why did this record match?
    Product Code :

    GQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.
    Device Description
    The Diagnostic Hybrids, Inc. D3 DFA VARICELLA-ZOSTER IDENTIFICATION KIT includes a DFA Reagent that contains a blend of two fluorescein-labeled murine monoclonal antibodies directed against VZV antigens. The kit includes the following components: VZV DFA Reagent, Mounting Fluid, VZV Antigen Control Slides, PBS Concentrate.
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    K Number
    K990141
    Device Name
    LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
    Manufacturer
    LIGHT DIAGNOSTICS
    Date Cleared
    1999-10-19

    (273 days)

    Product Code
    GQW, GQN
    Regulation Number
    866.3900
    Why did this record match?
    Product Code :

    GQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay is a direct immunofluorescence test intended for the simultaneous detection and identification of HSV 1 and 2 and varicella-zoster virus (VZV) from patients with vesicular, oral, genital, or skin lesions, and following amplification of virus in culture. Specimens found to be negative on direct specimen examination should be tested by cell culture.
    Device Description
    Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay utilizes a single reagent for the simultaneous detection and identification of HSV and VZV. The primary component, specific for both HSV 1 and 2 will bind to 155kD major capsid protein in HSV-infected cells. The secondary component, specific for VZV, will bind to glycoprotein gp I and the immediate early antigen in VZV-infected cells. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. When a FITC filter set is used, the HSV antigen-antibody complex will exhibit an apple green fluorescence and the VZV antigen-antibody complex will fluoresce yellow-gold. Uninfected cells stain a dull red due to the presence of Evans blue in the reagent. A blend of monoclonal antibodies directed against HSV and VZV is used in the Light Diagnostics SimulFluor™ HSV/VZV reagent. The use of monoclonal antibodies ensures increased specificity of the reagent and reduces the risk of non-specific background or interference.
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    K Number
    K964872
    Device Name
    VZV ANTIGEN CONTROL SLIDES
    Manufacturer
    VIRAL ANTIGENS, INC.
    Date Cleared
    1997-03-18

    (103 days)

    Product Code
    GQW
    Regulation Number
    866.3900
    Why did this record match?
    Product Code :

    GQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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