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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, immunoglobulins (d, e)
Product CodeJHR
Regulation Number 866.5510
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4
Non Reproducible Results 4 4
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 1 1

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