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ARK Fentanyl II Assay
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 5069-0001-00
Identity
- Trade Name
- ARK Fentanyl II Assay EUDAMEDARK™ Fentanyl II Assay FDA UDI
- Generic Name
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Fentanyl II Assay EUDAMEDThe ARK™ Fentanyl II Assay 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
- 5069-0001-00 EUDAMEDFDA UDI
- Description
- The ARK™ Fentanyl II Assay 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
- 5069-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030561 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003FEN069Y8 EUDAMED
- Direct Marketing DI
- 00812101030561 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
ARK Fentanyl II Assay by Ark Diagnostics Inc — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200197 | Class B | Active |
| FDA 510(k) | United States | FDA_510K | K180427 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 0858724003FEN069Y8 | Class B | Active |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED edff225d-45d0-4567-b2cf-f22ffc2bd007 61 fields · synced Jul 19, 2026
- FDA UDI d44789cd-0e9e-4cf5-954f-039f725a28cd 36 fields · synced May 30, 2026
- FDA 510(k) K200197 1 fields · synced May 18, 2026