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LACTOFERRIN CHEK
TECHLAB, INC. · Model T5008 · UDI-DI 00857031002271
DEG
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
10
Facilities
Description
The LACTOFERRIN CHEK test is an ELISA 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 irritable bowel syndrome (IBS), which is noninflammatory.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-27 | IMMUNDIAGNOSTIK, Inc | Marketed without a 510k |
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