Identity
- Trade Name
- ELISA Gliadin IgG Smart Kit Test System FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS 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
- SM2Z61001G FDA UDI
- Description
- The ZEUS 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
- SM2Z61001G FDA UDI
- Primary DI / UDI-DI
- 00845533000611 FDA UDI
- GMDN Term
- Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
No
FDA UDI
Category: Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Gliadin IgG Smart Kit Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA).
- AESKULISA® DGP-Check — Aesku.Diagnostics GmbH & Co. KG · Class II
- Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA — American Laboratory Products Company · Class II
- AESKULISA® DGP-G — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® DGP-A — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® Glia-G — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® DGP-Check — Aesku.Diagnostics GmbH & Co. KG · Class II
- Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA — American Laboratory Products Company · Class II
- AESKULISA® DGP-G — Aesku.Diagnostics GmbH & Co. KG · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 81898a17-479e-42e4-88b7-321516662634 35 fields · synced Jun 6, 2026