Identity
- Trade Name
- ARK™ Ethyl Glucuronide Assay FDA UDI
- Generic Name
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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
- Model / Reference
- 5036-0004-00 FDA 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
- 5036-0004-00 FDA UDI
- Primary DI / UDI-DI
- 00858724003605 FDA UDI
- GMDN Term
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)
ARK™ Ethyl Glucuronide Assay by Ark Diagnostics Inc — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA).
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- ARK™ Ethyl Glucuronide Assay — ARK DIAGNOSTICS INC
- ARK™ Ethyl Glucuronide Assay — ARK DIAGNOSTICS INC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (2)
- FDA UDI 89d3f998-0f0b-4e80-9327-f2c213228bbe 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026