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Radioimmunoassay, Tricyclic Antidepressant Drugs
FDA product code LFG · Class 2 · Clinical Toxicology
1,162
Registered devices
8
Adverse events
2
Recalls
21
510(k) clearances
Devices with this code
ToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONU-Screen — Instant Tech Subsidiary AcquisitionRTCII 2nd gen. — AMERICAN BIO MEDICA CORPORATIONEasy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONPROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.iCup® — Instant Technologies, Inc.DrugCheck — Express Diagnostic Int'l, Inc.Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) — MERGERS MARKETING, INC.iCup® — Instant Technologies, Inc.Healgen — Healgen Scientific Limited Liability CompanyOne-Step — W.H.P.M. INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.Healgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup 13 — CHEMTRON BIOTECH INCEasy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONNOBLE — NOBLE MEDICAL INCAmediCheck Instant Test Cup — AMEDITECH INC.Rapid TOX — AMERICAN BIO MEDICA CORPORATIONHealgen — Healgen Scientific Limited Liability CompanyHealgen — Healgen Scientific Limited Liability CompanyAlereTM iScreen® — Instant Technologies, Inc.DrugCheck — Express Diagnostic Int'l, Inc.SAFECUP III 13 PANEL — GERMAINE LABORATORIES, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not imp |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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