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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device igm (mu chain specific), antigen, antiserum, control
Product CodeDAO
Regulation Number 866.5550
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1
2024 5 5

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6

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