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U.S. Department of Health and Human Services

Product Classification

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Device material, quality control, semen analysis
Regulation Description Hematology quality control mixture.
Definition A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as ph, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeNRF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.8625
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible