← Back to catalogue
ARK Pregabalin II Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5059-0002-00Model 5059-0001-00
Identity
- Trade Name
- ARK Pregabalin II Calibrator EUDAMEDARK™ Pregabalin II Calibrator FDA UDI
- Generic Name
- Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- ARK Pregabalin II Assay EUDAMEDARK™ Pregabalin II Calibrator is intended for use in calibration of the ARK™ Pregabalin II Assay. FDA UDI
- Model / Reference
- 5059-0001-00 EUDAMED5059-0002-00 EUDAMEDFDA UDI
- Description
- ARK™ Pregabalin II Calibrator is intended for use in calibration of the ARK™ Pregabalin II Assay. FDA UDI
Identifiers
- Catalog Number
- 5059-0002-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030455 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003PGB0592C EUDAMED
- Direct Marketing DI
- 00812101030455 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3200 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 Calibrator 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARK Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000023925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 83a47d51-9379-443d-940a-7c4bb0240556 61 fields · synced Jun 18, 2026
- FDA UDI c74cbee8-b95e-40f4-89f8-1946f829c2b1 36 fields · synced May 25, 2026