ACCURUN 501 C. difficile Control is designed for use with in vitro diagnostic assays that detect C .difficile DNA. ACCURUN 501 C. difficile Control is manufactured from cultured Clostridium bacteria of four different strains or species. The bacteria are inactivated and in a human synthetic stool matrix which contains human proteins and genomic DNA. Vial A501-01 contains cultured C. difficile NAP1/027/B1 hypervirulent strain (strain BAA-1870). Vial A501-02 contains cultured toxigenic C. difficile strain (strain 43255). Vial A501-03 contains cultured non-toxigenic C. difficile strain (strain 43593). Vial A501-04 contains cultured Clostridium sordelli (strain 9714). For in vitro diagnostic use. Regulatory Status: IVD, CE