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ARK Fentanyl II Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5069-0001-01Model 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 detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. FDA UDI
- Model / Reference
- 5069-0001-00 EUDAMED5069-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ 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
- 5069-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00812101030578 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003FEN069Y8 EUDAMED
- Direct Marketing DI
- 00812101030578 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 — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0858724003FEN069Y8 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9b6a8fd1-4fb3-4b26-8652-9e0f41d2a0fc 61 fields · synced Jun 20, 2026
- FDA UDI 1cc57c7d-b6e6-4f6a-a8b7-a03a937679b1 36 fields · synced May 30, 2026