Identity
- Trade Name
- ELISA Gliadin IgA 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 IgA Test System is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test 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
- SM2Z61001A FDA UDI
- Description
- The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test 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
- SM2Z61001A FDA UDI
- Primary DI / UDI-DI
- 00845533000598 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 IgA Smart Kit Test System by Zeus Scientific, Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 2255ae02-5ff5-499d-817d-b277d61c8fee 35 fields · synced May 30, 2026