Identity
- Trade Name
- QuickVue TLI H. pylori Stool Antigen Test FDA UDI
- Generic Name
- Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. FDA UDI
- Model / Reference
- 20343 FDA UDI
- Description
- The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002622 FDA UDI
- 510(k) Number
- K181379 FDA UDI
- FDA Product Code
- LYR FDA UDI
- GMDN Term
- Helicobacter pylori antigen 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
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
Yes
FDA UDI
Category: Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)
QuickVue TLI H. pylori Stool Antigen Test by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
- H. PYLORI CHEK — TECHLAB, INC. · Class I
- H. PYLORI QUIK CHEK — TECHLAB, INC. · Class I
Cleared under the same submission
K181379 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 |
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Manufacturer
- Manufacturer
- Techlab, Inc.
Sources (1)
- FDA UDI b8f30c7b-5e4d-40e8-bd3e-8892076cdc8e 34 fields · synced Jun 8, 2026