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ARK Ethyl Glucuronide Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref 5036-0003-01Model 5036-0001-00
Identity
- Trade Name
- ARK Ethyl Glucuronide Control EUDAMEDARK™ Ethyl Glucuronide Control (750/1250) FDA UDI
- Generic Name
- Ethyl glucuronide (EtG) IVD, control FDA UDI
- Device Name
- ARK Ethyl Glucuronide Assay EUDAMEDARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. FDA UDI
- Model / Reference
- 5036-0001-00 EUDAMED5036-0003-01 EUDAMEDFDA UDI
- Description
- ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. FDA UDI
Identifiers
- Catalog Number
- 5036-0003-01 FDA UDI
- Primary DI / UDI-DI
- 00858724003506 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858724003ETG03633 EUDAMED
- Direct Marketing DI
- 00858724003506 EUDAMED
- FDA Product Code
- LAS FDA UDI
- EMDN Code
- W0102152009 CONTROLS FOR NARCOTICS / TOXICOLOGY EUDAMED
- GMDN Term
- Ethyl glucuronide (EtG) 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 Ethyl Glucuronide 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 | 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 b1ff58a9-6bcf-4b6d-bc00-58a433d2e463 61 fields · synced Jul 12, 2026
- FDA UDI 2902dac0-506d-4763-9730-5089547cb66d 36 fields · synced May 29, 2026