Identity
- Trade Name
- ARK™ Fentanyl Assay FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5031-0001-00 FDA UDI
- Description
- The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5031-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003407 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Opiate/opiate metabolite 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: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
ARK™ Fentanyl Assay by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8cd263d6-6093-45e2-a198-75527865eb76 36 fields · synced May 31, 2026