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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ldl & vldl precipitation, hdl
Product CodeLBR
Regulation Number 862.1475
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 5 5
Non Reproducible Results 4 4
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 3 3

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