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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay, pregnanediol glucuronide, over the counter
Definition Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
Product CodeQKE
Regulation Number 862.1620
Device Class 1


Premarket Reviews
ManufacturerDecision
MFB FERTILITY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 1 1
Device Displays Incorrect Message 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ectopic Pregnancy 1 1
Hemorrhage/Bleeding 1 1

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