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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, general purpose, microbiology, diagnostic
Product CodeLIB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 1 1
Contamination 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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