Identity
- Trade Name
- Adenovirus Antigen (stool) ELISA FDA UDI
- Generic Name
- Adenovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.IVD Research FDA UDI
- Model / Reference
- EIA-3444 FDA UDI
- Description
- The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.IVD Research FDA UDI
Identifiers
- Catalog Number
- EIA-3444 FDA UDI
- Primary DI / UDI-DI
- 00840239034441 FDA UDI
- FDA Product Code
- GNY FDA UDI
- GMDN Term
- Adenovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3020 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adenovirus Antigen (stool) ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 1b99bf7e-1b4a-4162-8ce1-8e74034706a0 37 fields · synced May 31, 2026