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LACTOFERRIN EZ VUE

TECHLAB, INC. · Model T5018 · UDI-DI 00857031002356

DEG Prescription

510(k) clearances

Adverse events

Recalls

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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Data 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.