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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The device may be composed of a collection apparatus and / or measurement assay.
Technical Method Serum or urine are collected and analyzed for the presence of antidepressant drugs.
Target Area Serum or urine.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLFG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3910
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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