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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calprotectin, fecal
Regulation Description Fecal calprotectin immunological test system.
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.
Product CodeNXO
Regulation Number 866.5180
Device Class 2