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510(k) Data Aggregation

    K Number
    K955362
    Device Name
    INCSTAR HSV I/II IGG FAST ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-24

    (245 days)

    Product Code
    IGC
    Regulation Number
    864.4010
    Why did this record match?
    Product Code :

    IGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to herpes simplex virus type 1 and/or type 2 in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the INCSTAR Herpes Simplex Virus I/II IgG "fast" ELISA test is of value in the determination of immunological response to infection with HSV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection with herpes simplex virus.
    Device Description
    The method for the determination of specific anti-HSV type 1 and/or type 2 IgG utilizes the enzyme-linked immunosorbent assay (ELISA) technique. Polystyrene microtiter wells are coated with purified HSV type 1 and type 2 antigens. Diluted patient serum is incubated with the purified HSV antigens bound to the solid surface of the microtiter well. The HSV type 1 and/or type 2 IgG antibodies present in a patient's serum will be captured by the solid phase. After washing, affinity purified polyclonal goat anti-human IgG (Fc) antibodies conjugated to horseradish peroxidase are added to the well. After this incubation, chromogen containing tetramethylbenzidine is added. Enzyme action on the chromogen results in a color reaction. The color can be detected with a photometer at a wavelength of 450 nm. The measured enzyme activity is directly proportional to the concentration of specific anti-HSV IgG bound to the solid phase.
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    K Number
    K955363
    Device Name
    INCSTAR HSZ I/II IGG ELISA ASSAY
    Manufacturer
    INCSTAR CORP.
    Date Cleared
    1996-07-24

    (245 days)

    Product Code
    IGC
    Regulation Number
    864.4010
    Why did this record match?
    Product Code :

    IGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
    Ask a Question

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