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ARK HS Benzodiazepine II Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5073-0001-01Model 5073-0001-00
Identity
- Trade Name
- ARK HS Benzodiazepine II Assay EUDAMEDARK™ HS Benzodiazepine II Assay FDA UDI
- Generic Name
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK HS Benzodiazepine II Assay EUDAMEDThe ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines in human urine at cutoff concentrations of 100 ng/mL and 200 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting benzodiazepines in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5073-0001-00 EUDAMED5073-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines in human urine at cutoff concentrations of 100 ng/mL and 200 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting benzodiazepines in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5073-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00812101030486 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003BZD0733F EUDAMED
- Direct Marketing DI
- 00812101030486 EUDAMED
- FDA Product Code
- JXM FDA UDI
- EMDN Code
- W0102090104 BENZODIAZEPINES EUDAMED
- GMDN Term
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3170 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 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 | 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 2422065a-2e7e-4547-992d-9763e94e25f4 61 fields · synced Jul 25, 2026
- FDA UDI 9145665b-cc39-41b9-b9a3-3128eea88475 36 fields · synced May 30, 2026