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QuickVue TLI Lactoferrin Test
TECHLAB, INC. · Model 20345 · UDI-DI 00857031002585
DEG
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
10
Facilities
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).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-27 | IMMUNDIAGNOSTIK, Inc | Marketed without a 510k |
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