Identity
- Trade Name
- QuickVue TLI Lactoferrin Test FDA UDI
- Generic Name
- Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The QuickVue TLI Lactoferrin Test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FDA UDI
- Model / Reference
- 20345 FDA UDI
- Description
- The QuickVue TLI Lactoferrin Test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002585 FDA UDI
- 510(k) Number
- K030704 FDA UDI
- FDA Product Code
- DEG FDA UDI
- GMDN Term
- Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5570 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: Lactoferrin IVD, kit, rapid ICT, clinical
QuickVue TLI Lactoferrin Test by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactoferrin IVD, kit, rapid ICT, clinical.
- Axim Biotechnologies T-POC Lactoferrin Immunoassay Kit — Axim Biotechnologies, Inc.
- LACTOFERRIN EZ VUE — TECHLAB, INC. · Class I
- LACTOFERRIN EZ VUE — TECHLAB, INC. · Class I
- LEUKO EZ VUE — TECHLAB, INC. · Class I
Cleared under the same submission
K030704 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 57bee78c-c355-49cd-b2f7-474052cea350 34 fields · synced May 29, 2026