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    K Number
    K212447
    Device Name
    SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
    Manufacturer
    Hangzhou Sejoy Electronics & Instruments Co., Ltd.
    Date Cleared
    2022-02-18

    (197 days)

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

    **Hangzhou Sejoy Electronics **& Instruments Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SEIOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
    Device Description
    Sejoy HCG One Step Pregnancy Test will be sold in three different formats:Strip,Cassette,and Midstream.The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device,a disposable plastic dropper,and a package insert.
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