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Calprotectin, Fecal

FDA product code NXO · 13 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5180
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-11-10 – 2024-02-06

The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.

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