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ARK Ketamine Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5056-0001-01Model 5056-0001-00
Identity
- Trade Name
- ARK Ketamine Assay EUDAMEDARK™ Ketamine Assay (115mL) FDA UDI
- Generic Name
- Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Ketamine Assay EUDAMEDThe ARK™ Ketamine Assay is intended for the qualitative and semiquantitative determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5056-0001-00 EUDAMED5056-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ Ketamine Assay is intended for the qualitative and semiquantitative determination of ketamines in human urine at a cutoff concentration of 50 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ketamines in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5056-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00812101030011 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003KET0563D EUDAMED
- Direct Marketing DI
- 00812101030011 EUDAMED
- FDA Product Code
- DKZ FDA UDI
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
- GMDN Term
- Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3100 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 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 | 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 af6ff611-0fe2-4d1e-af2e-04d9b5b48631 61 fields · synced Jun 18, 2026
- FDA UDI cb7060d4-81d3-45b4-9301-bd66b47631a7 36 fields · synced May 30, 2026