We are very pleased to announce the United States Food and Drug Administration (FDA) 510(k) clearance for the BÜHLMANN CALEX® Cap, a fecal extraction device, that can now be used with the FDA cleared BÜHLMANN fCAL® turbo fecal calprotectin in vitro test in the US. The fecal extraction device offers an easy, efficient and hygenic extraction for stool samples and is suitable for air and land transportation. In conjunction with the FDA cleared BÜHLMANN fCAL® turbo, an immuno turbidimetric fecal calprotectin assay, it offers the tools for Total Laboratory Automation in stool calprotectin measurement routine for a modern lab environment. The BÜHLMANN calprotectin assays are intended for the quantitative measurement of fecal calprotectin, a biomarker of mucosal inflammation to diagnose and monitor inflammatory bowel disease.
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