Identity
- Trade Name
- DRI™ Fentanyl II Assay FDA UDI
- Generic Name
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. FDA UDI
- Model / Reference
- 10028872 FDA UDI
- Description
- The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. FDA UDI
Identifiers
- Catalog Number
- 10028872 FDA UDI
- Primary DI / UDI-DI
- 00812101030752 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Fentanyl IVD, kit, enzyme immunoassay (EIA) 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
Yes
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: Fentanyl IVD, kit, enzyme immunoassay (EIA)
DRI™ Fentanyl II Assay by Ark Diagnostics Inc — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fentanyl IVD, kit, enzyme immunoassay (EIA).
- Fentanyl Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Fentanyl II Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Pointe Fentanyl (Qualitative) Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- LZI Fentanyl (Q) Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Immunalysis — Immunalysis Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (2)
- FDA UDI add8bb87-ef9b-467e-a887-6002a0064b01 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026