NXO

15 FDA 510(k) clearances · Product code

FDA profile

Official device name

Calprotectin, Fecal

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5180

Medical specialty

Immunology

Flags

Third-party review eligible

FDA definition

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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