Identity
- Trade Name
- AESKULISA® DGP-Check FDA UDI
- Generic Name
- Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). FDA UDI
- Model / Reference
- 3515 FDA UDI
- Description
- AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250289503679 FDA UDI
- 510(k) Number
- K132082 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)
AESKULISA® DGP-Check by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA).
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- ELISA Gliadin IgG Test System — ZEUS SCIENTIFIC, INC.
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- ELISA Gliadin IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- QUANTA Lite® h-tTG /DGP Screen ELISA — INOVA DIAGNOSTICS, INC. · Class II
- ELISA Gliadin IgA Test System — ZEUS SCIENTIFIC, INC.
Cleared under the same submission
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
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI b08dbbae-c3a2-44ac-9213-abca49a1f2c8 35 fields · synced May 30, 2026