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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodePOV
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
BONRAYBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ELECTRONIC SYSTEMS , LTD.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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