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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nad reduction/nadh oxidation, lactate dehydrogenase
Regulation Description Lactate dehydrogenase test system.
Product CodeCFJ
Regulation Number 862.1440
Device Class 2

MDR Year MDR Reports MDR Events
2021 10 10
2022 8 8
2023 3 3
2024 10 10
2025 12 12
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 28 28
Non Reproducible Results 20 20
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Low Test Results 3 3
Incorrect Measurement 2 2
Insufficient Information 2 2
Chemical Problem 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
No Known Impact Or Consequence To Patient 3 3

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