Identity
- Trade Name
- VERDICT®-II FDA UDI
- Generic Name
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A qualitative one-step immunochromatographic test for the detection of Tricyclic Antidepressants and/or metabolites in human urine. FDA UDI
- Model / Reference
- 601629 FDA UDI
- Description
- A qualitative one-step immunochromatographic test for the detection of Tricyclic Antidepressants and/or metabolites in human urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00690286000193 FDA UDI
- FDA Product Code
- LFG FDA UDI
- GMDN Term
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tricyclic antidepressant IVD, kit, rapid ICT, clinical
Verdict®-Ii by Medtox Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002331 also covers:
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- EZ-SCREEN® CUP — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-II — MEDTOX DIAGNOSTICS, INC.
- PROFILE®-IIA — MEDTOX DIAGNOSTICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtox Diagnostics, Inc.
Sources (1)
- FDA UDI 23f10063-9e89-48d3-adc9-212399b58402 36 fields · synced Jun 8, 2026