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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, valproic acid
Regulation Description Neuroleptic drugs radioreceptor assay test system.
Product CodeLEG
Regulation Number 862.3645
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 19 19
2023 1 1
2024 14 14
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 37 37
High Test Results 31 31
Non Reproducible Results 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Measurement 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52

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