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510(k) Data Aggregation
K Number
K024337Device Name
GENERAL SEMEN ANALYSIS (GSA) KIT
Manufacturer
Date Cleared
2003-07-03
(188 days)
Regulation Number
864.5220Why 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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