Identity
- Trade Name
- Eu-tTG IgG FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml). 4. Control 1: 1x1.5 mL vial. 5. Control 2: 1x1.5 mL vial. 6. Sample Diluent (10x): 1 x20mL vial. 7. Substrate: 1 x15 ml vial. 8. Wash solution (20x): 1x50 mL vial. 9. Stop Solution: 1 x15 ml vial. FDA UDI
- Model / Reference
- 9166 FDA UDI
- Description
- 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml). 4. Control 1: 1x1.5 mL vial. 5. Control 2: 1x1.5 mL vial. 6. Sample Diluent (10x): 1 x20mL vial. 7. Substrate: 1 x15 ml vial. 8. Wash solution (20x): 1x50 mL vial. 9. Stop Solution: 1 x15 ml vial. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08028169204048 FDA UDI
- 510(k) Number
- K102964 FDA UDI
- FDA Product Code
- MVM FDA UDI
- GMDN Term
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 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
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: Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
Eu-tTG IgG by Eurospital — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® h-tTG Screen ELISA — INOVA DIAGNOSTICS, INC. · Class II
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- AESKULISA tTg-G New Generation — Aesku.Diagnostics GmbH & Co. KG · Class II
- QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp) — INOVA DIAGNOSTICS, INC. · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA — American Laboratory Products Company · Class II
- Anti-tissue Transglutaminase ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- QUANTA Lite® R h-tTG IgA ELISA — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K102964 also covers:
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
- Eurospital
Sources (1)
- FDA UDI 35b7d4b4-8166-44f8-b1cc-b6688055bbad 36 fields · synced Jun 8, 2026