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U.S. Department of Health and Human Services

Product Classification

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Device semen analysis device
Regulation Description Automated differential cell counter.
Definition Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Physical State Semen analysis devices may be found in a range of shapes and sizes with various distinguishing features.
Technical Method The device may use one or more forms of technology including optical, mechanical, digital imaging, computer algorithms, chromatographic immunoassay and may be manual, automated, or semi-automated.
Target Area Human semen
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePOV
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons