Identity
- Trade Name
- ARK Tramadol Assay EUDAMEDARK™ Tramadol Assay FDA UDI
- Generic Name
- Tramadol IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Tramadol Assay EUDAMEDThe ARK™ Tramadol Assay is intended for the qualitative and/or semiquantitative determination of tramadol in human urine at a cutoff concentration of 100ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5040-0001-00 EUDAMEDFDA UDI
- Description
- The ARK™ Tramadol Assay is intended for the qualitative and/or semiquantitative determination of tramadol in human urine at a cutoff concentration of 100ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5040-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003773 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003TRA0406V EUDAMED
- Direct Marketing DI
- 00858724003773 EUDAMED
- 510(k) Number
- K182280 FDA UDI
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Tramadol 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 Tramadol 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 | 0858724003TRA0406V | 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 68b4ba77-967b-44e9-ae8a-4c21fc0957e9 61 fields · synced Sep 17, 2026
- FDA UDI 26d36650-9bf1-46d5-8269-3bbc0f7d44b9 37 fields · synced May 29, 2026