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510(k) Data Aggregation

    K Number
    K024337
    Device Name
    GENERAL SEMEN ANALYSIS (GSA) KIT
    Manufacturer
    Date Cleared
    2003-07-03

    (188 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOSHAF LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GSA kit is for the evaluation of human semen. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four (4) parameters recommended by the World Health Organization (WHO) that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: - . Sperm count - Sperm motility . - Sperm vitality t - . White blood cell (WBC) count
    Device Description
    The GSA kit is an in vitro diagnostic kit intended for use in a clinical laboratory test setting such as a test facility capable of providing laboratory assessment of male infertility, by skilled laboratory technicians, familiar with the handling of semen samples. This product does not contain biological materials of human origin. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four parameters, recommended by the World Health Organization (WHO), that are used to help determine whether infertility is caused by abnormalities of one or more of them. The parameters to be tested for include: - . Sperm count - Sperm motility - . Sperm vitality - White blood cell (WBC) count .
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