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    K Number
    K222305
    Device Name
    MissLan™ Digital Pregnancy Rapid Test
    Manufacturer
    Guangzhou Decheng Biotechnology Co. Ltd.
    Date Cleared
    2022-11-30

    (121 days)

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

    Guangzhou Decheng Biotechnology Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MissLan™ Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
    Device Description
    MissLan™ Digital Pregnancy Rapid Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.
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