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ARK HS Benzodiazepine II Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5073-0003-01Model 5073-0001-00
Identity
- Trade Name
- ARK HS Benzodiazepine II Control EUDAMEDARK™ HS Benzodiazepine II 150/250ng/mL Control FDA UDI
- Generic Name
- Benzodiazepine group IVD, control FDA UDI
- Device Name
- ARK HS Benzodiazepine II Assay EUDAMEDARK™ HS Benzodiazepine II 150/250ng/mL Control is intended for use in quality control of the ARK™ HS Benzodiazepine II Assay. FDA UDI
- Model / Reference
- 5073-0001-00 EUDAMED5073-0003-01 EUDAMEDFDA UDI
- Description
- ARK™ HS Benzodiazepine II 150/250ng/mL Control is intended for use in quality control of the ARK™ HS Benzodiazepine II Assay. FDA UDI
Identifiers
- Catalog Number
- 5073-0003-01 FDA UDI
- Primary DI / UDI-DI
- 00812101030554 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003BZD0733F EUDAMED
- Direct Marketing DI
- 00812101030554 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Benzodiazepine group 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 HS Benzodiazepine II 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 | 0858724003BZD0733F | 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 f07e4d35-89bc-4141-abf2-df8c1ea8e48a 61 fields · synced Jun 19, 2026
- FDA UDI 0f0e825a-5dd0-4b06-a54b-4eb1f31ed021 36 fields · synced May 30, 2026