Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA FDA UDI
- Model / Reference
- 425-2260 FDA UDI
- Description
- Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA FDA UDI
Identifiers
- Catalog Number
- 4252260 FDA UDI
- Primary DI / UDI-DI
- 00847817018336 FDA UDI
- 510(k) Number
- K042644 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
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
Yes
FDA UDI
Category: Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® h-tTG Screen ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp) — INOVA DIAGNOSTICS, INC. · Class II
- 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
- 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
- Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA — American Laboratory Products Company · Class II
Cleared under the same submission
K042644 also covers:
- AESKULISA tTg-A New Generation — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA tTg-A New Generation — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA tTg-G New Generation — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA tTg-G New Generation — Aesku.Diagnostics GmbH & Co. KG
- Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA — American Laboratory Products Company
- Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA — American Laboratory Products Company
- Autoimmune EIA — Bio-Rad Laboratories
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 4c50979a-7aef-4cf3-936e-8af58520833b 38 fields · synced May 30, 2026