Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Captia™ H. pylori IgG FDA UDI
- Model / Reference
- 2346400 FDA UDI
- Description
- Captia™ H. pylori IgG FDA UDI
Identifiers
- Catalog Number
- 2346400 FDA UDI
- Primary DI / UDI-DI
- 05391516743679 FDA UDI
- 510(k) Number
- K033067 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3110 FDA UDI
- 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: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Trinity Biotech by Clark Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® H.pylori IgG ELISA — INOVA DIAGNOSTICS, INC. · Class I
- Status™ H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- ELISA H. pylori IgG Test System — ZEUS SCIENTIFIC, INC.
- ELISA H. pylori IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- VIDAS® H. pylori IgG — BIOMERIEUX , INC. · Class I
- Status™ H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- BioSign® H. pylori card — PRINCETON BIOMEDITECH CORP. · Class I
- GAP®-IgG (Gastritis and Peptic Ulcer Test) — BIOMERICA, INC. · Class I
Cleared under the same submission
K033067 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI 2796ede2-47e0-4f94-a3ff-ca2f580c345d 38 fields · synced May 30, 2026