Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Gliadin IgG Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) AccuDiag ™ Gliadin IgG ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-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. This test is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- DACD-1021-2 FDA UDI
- Description
- AccuDiag ™ Gliadin IgG Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) AccuDiag ™ Gliadin IgG ELISA Gliadin IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-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. This test is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 1021-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000428 FDA UDI
- FDA Product Code
- MST FDA UDI
- GMDN Term
- Multiple Coeliac disease-associated 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
No
FDA UDI
Category: Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 783920ca-59ca-474f-aab8-731fb4c55210 37 fields · synced May 30, 2026