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510(k) Data Aggregation

    K Number
    K962906
    Device Name
    SCRIPPS LABORATORIES HCG ONE-STEP
    Date Cleared
    1996-08-23

    (29 days)

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

    SCRIPPS LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use.
    Device Description
    HCG is a hormone produced and secreted by the placenta following implantation. Its early presence and rapid increase in maternal urine make it an excellent marker for use in the diagnosis of pregnancy. Scripps Laboratories hCG One-Step uses monoclonal and polyclonal antibody technology to specifically detect hCG in urine. The product is configured in a dipstick format. When the product is partially submerged in urine, the sample travels through the Test Strip. If hCG is present at levels of 25 mIU/ml (W.H.O. 3rd I.S. 75/537) or greater, a positive result, two distinct red bands will appear. If no hCG is present, a negative result, one red band, will appear.
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