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510(k) Data Aggregation

    K Number
    K123050
    Device Name
    EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
    Manufacturer
    NANTONG BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2013-02-05

    (130 days)

    Product Code
    LCX, JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANTONG BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users. EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users. EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) is a rapid chromatographic immunoassay for the qualitative detection of Human Choric Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users. EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.
    Device Description
    One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml. The test devices are in four different formats: Strip, Cassette, Midstream I , and Midstream II . The HCG assay is a rapid one-step test based on immunochromatographic technology. This device is composed of glass fiber strips of the monoclonal antibody against HCG, anti-mouse IgG, solid cellulose nitrate membrane, and the bonders of absorptive colloidal gold - monoclonal antibody against HCG. It adopts the principles of the double antibody sandwich method and imunochromatography technology to test for the presence of HCG in urine.
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