Identity
- Trade Name
- ARK™ Fentanyl Calibrator FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, calibrator FDA UDI
- Device Name
- ARK™ Fentanyl Calibrator is intended for use in calibration of the ARK™ Fentanyl Assay. FDA UDI
- Model / Reference
- 5031-0002-00 FDA UDI
- Description
- ARK™ Fentanyl Calibrator is intended for use in calibration of the ARK™ Fentanyl Assay. FDA UDI
Identifiers
- Catalog Number
- 5031-0002-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003414 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Commercial Distribution
- Not 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
ARK™ Fentanyl Calibrator by Ark Diagnostics Inc — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 fe8577a6-241f-4b3f-9cca-ed04b04e7129 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026