Identity
- Trade Name
- VERDICT®-II FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A qualitative one-step immunochromatographic test for the detection of Buprenorphine and/or metabolites in human urine. FDA UDI
- Model / Reference
- 601682 FDA UDI
- Description
- A qualitative one-step immunochromatographic test for the detection of Buprenorphine and/or metabolites in human urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00690286000544 FDA UDI
- 510(k) Number
- K100951 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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: Opiate/opiate metabolite 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
K100951 also covers:
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 43732a48-627c-44c1-a14a-0679ff0bbdea 36 fields · synced Jun 8, 2026