← Back to catalogue
ARK HS Benzodiazepine II Calibrator
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5073-0002-00Model 5073-0001-00
Identity
- Trade Name
- ARK HS Benzodiazepine II Calibrator EUDAMEDARK™ HS Benzodiazepine II Calibrator FDA UDI
- Generic Name
- Benzodiazepine group IVD, calibrator FDA UDI
- Device Name
- ARK HS Benzodiazepine II Assay EUDAMEDARK™ HS Benzodiazepine II Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay. FDA UDI
- Model / Reference
- 5073-0001-00 EUDAMED5073-0002-00 EUDAMEDFDA UDI
- Description
- ARK™ HS Benzodiazepine II Calibrator is intended for use in calibration of the ARK™ HS Benzodiazepine II Assay. FDA UDI
Identifiers
- Catalog Number
- 5073-0002-00 FDA UDI
- Primary DI / UDI-DI
- 00812101030509 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003BZD0733F EUDAMED
- Direct Marketing DI
- 00812101030509 EUDAMED
- FDA Product Code
- DLJ FDA UDI
- EMDN Code
- W0102152209 DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Benzodiazepine group 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 HS Benzodiazepine 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 | 0858724003BZD0733F | 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 0a75811d-9ac4-4618-afeb-1756fe0713aa 61 fields · synced Jul 10, 2026
- FDA UDI a54db921-1516-4cda-8a14-4ee5bb3713e0 36 fields · synced May 30, 2026