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ARK Ketamine Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5056-0003-00Model 5056-0001-00
Identity
- Trade Name
- ARK Ketamine Control EUDAMEDARK™ Ketamine Control FDA UDI
- Generic Name
- Ketamine/ketamine metabolite IVD, control FDA UDI
- Device Name
- ARK Ketamine Assay EUDAMEDARK™ Ketamine Control is intended for use in quality control of the ARK™ Ketamine Assay. FDA UDI
- Model / Reference
- 5056-0001-00 EUDAMED5056-0003-00 EUDAMEDFDA UDI
- Description
- ARK™ Ketamine Control is intended for use in quality control of the ARK™ Ketamine Assay. FDA UDI
Identifiers
- Catalog Number
- 5056-0003-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030059 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003KET0563D EUDAMED
- Direct Marketing DI
- 00812101030059 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Ketamine/ketamine metabolite IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3280 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 Ketamine Control 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 | 0858724003KET0563D | 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 f7102357-73fc-4c25-bc8d-0f1f78984e3f 61 fields · synced Jul 8, 2026
- FDA UDI 079f64b5-9d31-4c71-88e9-4939ce1b9d72 36 fields · synced May 30, 2026