Identity
- Trade Name
- Adenovirus IgG ELISA FDA UDI
- Generic Name
- Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum FDA UDI
- Model / Reference
- EIA-3446 FDA UDI
- Description
- The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum FDA UDI
Identifiers
- Catalog Number
- EIA-3446 FDA UDI
- Primary DI / UDI-DI
- 00840239034465 FDA UDI
- FDA Product Code
- GOD FDA UDI
- GMDN Term
- Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3020 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Adenovirus IgG ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- CHORUS ADENOVIRUS IgG — DIESSE DIAGNOSTICA SENESE SPA · Class I
- NovaLisa Adenovirus IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
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 7b004cf5-ca95-4402-be2b-c08ccc917b06 36 fields · synced May 30, 2026