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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
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 1
MEDICAL ELECTRONIC SYSTEMS, LTD
  SUBSTANTIALLY EQUIVALENT 1
MOTILITYCOUNT APS
  SUBSTANTIALLY EQUIVALENT 1
PRINCETON BIOMEDITECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
SANDSTONE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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