Identity
- Trade Name
- EL-tTG IgA/IgG FDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-TISSUE TRANS-GLUTAMINASE ANTIBODY ELISA TEST KIT FDA UDI
- Model / Reference
- 104-117 FDA UDI
- Description
- ANTI-TISSUE TRANS-GLUTAMINASE ANTIBODY ELISA TEST KIT FDA UDI
Identifiers
- Catalog Number
- 104-117 FDA UDI
- Primary DI / UDI-DI
- 00854473003217 FDA UDI
- 510(k) Number
- K071692 FDA UDI
- GMDN Term
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
EL-tTG IgA/IgG by Theratest Laboratories, Inc. — 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
- 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
K071692 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI 2fb770f4-f67b-4f24-86f6-33b6137ca4d0 36 fields · synced Jun 6, 2026