Identity
- Trade Name
- Gliadin IgA ELISA FDA UDI
- Generic Name
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG Gliadin IgA ELISA test system is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. FDA UDI
- Model / Reference
- EIA-3370 FDA UDI
- Description
- The DRG Gliadin IgA ELISA test system is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. FDA UDI
Identifiers
- Catalog Number
- EIA-3370 FDA UDI
- Primary DI / UDI-DI
- 04048474033700 FDA UDI
- 510(k) Number
- K990207 FDA UDI
- FDA Product Code
- MST FDA UDI
- GMDN Term
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
Gliadin IgA ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K990207 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
Sources (1)
- FDA UDI d2e5a83f-edf6-4984-9051-6ba9576b4507 37 fields · synced May 31, 2026