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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calprotectin, fecal
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


Premarket Reviews
ManufacturerDecision
ALPCO
  SUBSTANTIALLY EQUIVALENT 2
BUHLMANN LABORATORIES AG
  SUBSTANTIALLY EQUIVALENT 2
BÜHLMANN LABORATORIES AG
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
EUROSPITAL S.P.A.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Device Handling Problem 1 1

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