LEUKO EZ VUE

TECHLAB, INC. · Model T30355 · UDI-DI 00857031002172

DEG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing.

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.