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    K Number
    K992915
    Device Name
    ONE-STEP DOUBLE-CHEK PREGNANCY TEST
    Manufacturer
    BIOMEDICAL PRODUCTS CORP.
    Date Cleared
    1999-11-18

    (80 days)

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

    BIOMEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.
    Device Description
    The One-Step Double-Chek™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine and serum. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Double-Chek™ Pregnancy Test will detect hCG in urine and serum at a concentration level of 25 mIU/ml. The One-Step Double-Chek™ Pregnancy Test will be sold for professional use only.
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