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510(k) Data Aggregation

    K Number
    K972975
    Device Name
    LIGHT DIAGNOSTICS RABIES DFA REAGENT
    Manufacturer
    LIGHT DIAGNOSTICS
    Date Cleared
    1998-12-22

    (498 days)

    Product Code
    GOI
    Regulation Number
    866.3460
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    Product Code :

    GOI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Light Diagnostics Rabies DFA Reagent is intended for the detection of rabies antigens in culture and in acetone-fixed brain and submaxillary tissues of infected animals. Thus the assay could be used as an aid in the indirect diagnosis of human rabies virus infection. All specimens that are negative or indeterminate by DFA testing should be further tested by cell culture or animal inoculation methods.
    Device Description
    Light Diagnostics Rabies DFA Reagent uses fluorescein-labeled monoclonal antibodies directed against the rabies nucleocapsid protein to detect the virus in infected tissue. The direct immunofluorescence assay requires incubation of a user-determined dilution of the reagent with suspected rabies-infected tissue such as brain (medulla, cerebellum, and hippocampus) and submaxillary salivary glands. If virus is present, the FITC-labeled monoclonal antibodies will bind to the nucleocapsid protein. Unbound antibody is removed by washing. The antigen-antibody complex is visualized using fluorescence microscopy. Positive reactions in infected tissue will appear as bright apple-green cytoplasmic inclusions or "dusting". A blend of monoclonal antibodies are used in the Light Diagnostics Rabies DFA reagent. These monoclonal antibodies are specific for the rabies virus nucleocapsid protein. 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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