We are proud to announce the United States Food and Drug Administration (FDA) 510(k) clearance for the BÜHLMANN fCAL® turbo. The immuno turbidimetric fecal calprotectin assay was successfully launched all over the world and is now available in the U.S. market. The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin (FC), a biomarker of mucosal inflammation in human stool. It aids in the diagnosis of inflammatory bowel disease (IBD), specifically crohn’s disease (CD) and ulcerative colitis (UC). Furthermore it supports, in conjunction with other laboratory and clinical findings, the differentiation of IBD from irritable bowel syndrome (IBS). Utilizing BÜHLMANN fCAL® turbo for calprotectin diagnostic testing ensures speed, efficiency in workflow, accuracy and reproducibility over long periods of time as unbeatable key characteristics.
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