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ARK AB-PINACA Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5055-0002-02Model 5055-0001-00
Identity
- Trade Name
- ARK AB-PINACA Calibrator EUDAMEDARK™ AB-PINACA Cutoff Calibrator FDA UDI
- Generic Name
- Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator FDA UDI
- Device Name
- ARK AB-PINACA Assay EUDAMEDARK™ AB-PINACA Cutoff Calibrator is intended for use in calibration of the ARK™ AB-PINACA Assay. FDA UDI
- Model / Reference
- 5055-0001-00 EUDAMED5055-0002-02 EUDAMEDFDA UDI
- Description
- ARK™ AB-PINACA Cutoff Calibrator is intended for use in calibration of the ARK™ AB-PINACA Assay. FDA UDI
Identifiers
- Catalog Number
- 5055-0002-02 FDA UDI
- Primary DI / UDI-DI
- 00812101030370 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003ABP055V9 EUDAMED
- Direct Marketing DI
- 00812101030370 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Synthetic cannabinoid/synthetic cannabinoid metabolite 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 AB-PINACA 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 | 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 42162517-d3ad-4faa-a369-9db279691194 61 fields · synced Jun 19, 2026
- FDA UDI f605bd8a-b5a6-4cb2-9fa1-b068866c1a46 36 fields · synced May 30, 2026