Identity
- Trade Name
- DRI™ Fentanyl II Assay - 500mL FDA UDI
- Generic Name
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. FDA UDI
- Model / Reference
- 10028871 FDA UDI
- Description
- The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. FDA UDI
Identifiers
- Catalog Number
- 10028871 FDA UDI
- Primary DI / UDI-DI
- 00812101030769 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 - 500mL by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — 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 (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
- Ark Diagnostics Inc
Sources (1)
- FDA UDI 5127f5b8-50e7-413a-b5e5-d3534b64c284 36 fields · synced May 30, 2026