Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Ethyl Alcohol Enzyme Assay FDA UDI
- Model / Reference
- 504-0500 FDA UDI
- Description
- Ethyl Alcohol Enzyme Assay FDA UDI
Identifiers
- Catalog Number
- 504-0500 FDA UDI
- Primary DI / UDI-DI
- 00840937110379 FDA UDI
- 510(k) Number
- K181553 FDA UDI
- FDA Product Code
- DIC FDA UDI
- GMDN Term
- Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3040 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
No
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)
Immunalysis by Immunalysis Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA).
Cleared under the same submission
K181553 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 |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA UDI 54d3ad04-5415-4f2a-a4e6-8dbf3b4e24f3 36 fields · synced May 30, 2026