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LACTOFERRIN EZ VUE
TECHLAB, INC. · Model 30353 · UDI-DI 00857031002189
DEG
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
10
Facilities
Description
The LACTOFERRIN EZ VUE® 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
