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ARK Ethyl Glucuronide Assay
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5036-0001-01Model 5036-0001-00
Identity
- Trade Name
- ARK Ethyl Glucuronide Assay EUDAMEDARK™ Ethyl Glucuronide Assay (115mL) FDA UDI
- Generic Name
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ARK Ethyl Glucuronide Assay EUDAMEDThe ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 5036-0001-00 EUDAMED5036-0001-01 EUDAMEDFDA UDI
- Description
- The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 5036-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003476 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003ETG03633 EUDAMED
- Direct Marketing DI
- 00858724003476 EUDAMED
- EMDN Code
- W0102090220 ETHYL GLUCURONIDE EUDAMED
- GMDN Term
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMED
- 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 Ethyl Glucuronide 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 | 0858724003ETG03633 | 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 84aca978-73d3-4ff4-b521-e3a4858ead88 61 fields · synced May 30, 2026
- FDA UDI 96335fda-cc4f-49a7-bccf-c166308afb5e 36 fields · synced May 30, 2026