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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNRF
Regulation Number 864.8625
Device Class 2