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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device serology tests used for infectious disease screening of blood and plasma donations
Regulation Description Test requirements.
Definition For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
Product CodeQHM
Regulation Number 610.40
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 93 93
2022 116 116
2023 155 155
2024 45 45
2025 61 61
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 442 442
False Negative Result 38 38
Non Reproducible Results 3 3
Leak/Splash 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 481 481
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Known Impact Or Consequence To Patient 1 1

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