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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, dehydroepiandrosterone (free and sulfate)
Regulation Description Dehydroepiandrosterone (free and sulfate) test system.
Product CodeJKC
Regulation Number 862.1245
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2024 4 4
2025 6 6
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 16 16
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Low Test Results 3 3
Non Reproducible Results 2 2
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16

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