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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
Regulation Description Tricyclic antidepressant drugs test system.
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
Erratic Results 1 1
Unable to Obtain Readings 1 1

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

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