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LACTOFERRIN SCAN

TECHLAB, INC. · Model T5009 · UDI-DI 00857031002288

DEG Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
11
Facilities

Description

The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS).

Recalls

DateFirmReason
2023-03-27IMMUNDIAGNOSTIK, IncMarketed 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.