Identity
- Trade Name
- ARK™ Hydrocodone Assay FDA UDI
- Generic Name
- Pethidine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. FDA UDI
- Model / Reference
- 5076-0001-01 FDA UDI
- Description
- The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. FDA UDI
Identifiers
- Catalog Number
- 5076-0001-01 FDA UDI
- Primary DI / UDI-DI
- 00812101031070 FDA UDI
- 510(k) Number
- K231752 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Pethidine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Pethidine IVD, kit, enzyme immunoassay (EIA)
ARK™ Hydrocodone Assay by Ark Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pethidine IVD, kit, enzyme immunoassay (EIA).
- ARK™ Hydrocodone Assay — ARK DIAGNOSTICS INC · Class II
Cleared under the same submission
K231752 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ark Diagnostics Inc
Sources (1)
- FDA UDI ddd91c6f-4db8-46b8-92c7-5225e7af6da3 37 fields · synced May 31, 2026