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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, tricyclic antidepressant drugs
Definition Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Product CodeLFG
Regulation Number 862.3910
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
Unable to Obtain Readings 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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