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Radioimmunoassay, Tricyclic Antidepressant Drugs
FDA product code LFG · Class 2 · Clinical Toxicology
1,179
Registered devices
8
Adverse events
2
Recalls
21
510(k) clearances
Devices with this code
Healgen — Healgen Scientific Limited Liability CompanyT-Cup — WONDFO USA CO., LTD.NOBLE — NOBLE MEDICAL INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.BluRapids™ — MERCEDES MEDICAL, LLCDrugSmart Cup 13 — CHEMTRON BIOTECH INCHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCVERDICT®-II — MEDTOX DIAGNOSTICS, INC.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Healgen — Healgen Scientific Limited Liability CompanyCLIAwaived — Cliawaived, Inc.Healgen — Healgen Scientific Limited Liability CompanyAlereTM iScreen® — Instant Technologies, Inc.Healgen — Healgen Scientific Limited Liability CompanyHealgen — Healgen Scientific Limited Liability CompanyRapid TOX — AMERICAN BIO MEDICA CORPORATIONAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.FIRST SIGN® — HEMOSURE INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.Healgen — Healgen Scientific Limited Liability Company
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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