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ARK Pregabalin II Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5059-0001-00Ref 5059-0001-02
Identity
- Trade Name
- ARK Pregabalin II Assay EUDAMEDARK™ Pregabalin II Assay FDA UDI
- Generic Name
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- ARK Pregabalin II Assay EUDAMEDThe ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL. FDA UDI
- Model / Reference
- 5059-0001-00 EUDAMEDFDA UDI5059-0001-02 EUDAMED
- Description
- The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL. FDA UDI
Identifiers
- Catalog Number
- 5059-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030448 EUDAMEDFDA UDI00812101032169 EUDAMED
- Basic UDI-DI
- 0858724003PGB0592C EUDAMED
- Direct Marketing DI
- 00812101030448 EUDAMED00812101032169 EUDAMED
- FDA Product Code
- NWM FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Multiple anticonvulsant therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3350 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 Pregabalin 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 | 0858724003PGB0592C | 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 (3)
- EUDAMED fff03cf4-76ba-4f33-9e1e-9cdf134f1856 61 fields · synced Jul 23, 2026
- FDA UDI f20bcd44-550a-4917-9ae9-4923f72c5c16 36 fields · synced May 30, 2026
- EUDAMED 12a78e0c-da38-4d4a-80e6-9a72031a7e15 61 fields · synced Jul 12, 2026