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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, luteinizing hormone (lh), over the counter
Regulation Description Luteinizing hormone test system.
Product CodeNGE
Regulation Number 862.1485
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2024 1 1
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
2 Universal Meditech Inc. II Oct-23-2023
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