Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K232864
    Device Name
    EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
    Date Cleared
    2024-01-26

    (133 days)

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

    Nantong Egens Biotechnology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
    Device Description
    EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are 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 only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1