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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device colorimetric method, cpk or isoenzymes
Product CodeJHY
Regulation Number 862.1215
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 1 1

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