Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA Anti-Gliadin IgA FDA UDI
- Model / Reference
- 425-2220 FDA UDI
- Description
- Autoimmune EIA Anti-Gliadin IgA FDA UDI
Identifiers
- Catalog Number
- 4252220 FDA UDI
- Primary DI / UDI-DI
- 00847817018312 FDA UDI
- 510(k) Number
- K052439 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
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
Yes
FDA UDI
Category: Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gliadin antibody IVD, kit, enzyme immunoassay (EIA).
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- QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp) — INOVA DIAGNOSTICS, INC. · Class II
- a-GliaPep IgG — Eurospital · Class II
- QUANTA Lite® Gliadin IgA II ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® Gliadin IgG ELISA — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K052439 also covers:
- AESKULISA® Glia-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Glia-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Glia-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KG
- Autoimmune EIA — Bio-Rad Laboratories
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 0b2effb2-dc4a-4245-85e8-e58013dc5b58 38 fields · synced May 30, 2026