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510(k) Data Aggregation

    K Number
    K110309
    Device Name
    FOB ONE STEP RAPID TEST
    Manufacturer
    ORIENT GENE BIOTECH
    Date Cleared
    2011-09-14

    (224 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIENT GENE BIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
    Device Description
    The FOB One Step Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antibody-sandwich technique. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
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