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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)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeJHR
Regulation Number 866.5510
Device Class 2

MDR Year MDR Reports MDR Events
2023 4 4
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 9 9
Low Test Results 7 7
High Test Results 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9

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