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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, calcitonin
Product CodeJKR
Regulation Number 862.1140
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 3 3
2022 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
Non Reproducible Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3

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