Xpert FII & FV NOR/MUT Control is intended for in vitro use as a quality control to monitor analytical performance of FII & FV detection on the GeneXpert System. Xpert FII & FV NOR/MUT Control is formulated to monitor the detection of mutations Factor II G20210A and Factor V Leiden G1691A, the most common genetic risk factors for thrombotic events. Xpert FII & FV NOR/MUT Control consists of a suspension of synthetic Factor II and Factor V DNA in a proprietary matrix with preservatives. The kit is comprised of four bottles. Two bottles of Xpert FII & FV Normal Control contain wild type Factor II and Factor V DNA. Two bottles of Xpert FII & FV Mutant Control contain homozygous mutant Factor II and Factor V DNA. Xpert FII & FV NOR/MUT Control is comprised of four bottles containing 0.5mL each of synthetic Factor II and Factor V DNA suspended in a non-infectious matrix with carrier DNA, preservatives and stabilizers.