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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, estriol
Regulation Description Estriol test system.
Product CodeCGI
Regulation Number 862.1265
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11

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