Identity
- Trade Name
- ARK AB-PINACA Assay EUDAMEDARK™ AB-PINACA Assay FDA UDI
- Generic Name
- Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK AB-PINACA Assay EUDAMEDThe ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL. FDA UDI
- Model / Reference
- 5055-0001-00 EUDAMEDFDA UDI
- Description
- The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL. FDA UDI
Identifiers
- Catalog Number
- 5055-0001-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030349 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003ABP055V9 EUDAMED
- Direct Marketing DI
- 00812101030349 EUDAMED
- FDA Product Code
- LDJ FDA UDI
- EMDN Code
- W0102090105 CANNABINOIDS EUDAMED
- GMDN Term
- Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3870 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 AB-PINACA 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 | 0858724003ABP055V9 | 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 7c013799-41d9-4f58-bcac-94409ee697df 61 fields · synced Jun 18, 2026
- FDA UDI 753df8f8-9c41-42b6-a1d8-0ca16ec0f4b2 36 fields · synced May 30, 2026