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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, cf (including cf control), influenza virus a, b, c
Product CodeGNX
Regulation Number 866.3330
Device Class 1

MDR Year MDR Reports MDR Events
2021 36 36
2022 32 32
2023 61 61
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 111 111
Incorrect, Inadequate or Imprecise Result or Readings 18 18
False Negative Result 2 2
Expiration Date Error 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 132 132
No Consequences Or Impact To Patient 4 4

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