Clinical chemistry vitamin and mineral IVDs

Intended purpose

Our applicant devices are provided as laboratory internal quality controls. Therefore they will typically be run by end users at defined intervals to monitor precision of testing systems and in identifying sources of variation. The Active Vitamin B12 Control is intended for use with in vitro diagnostic assays for the quantitative determination of Holotranscobalamin (HoloTC) in human serum and plasma, on a variety of analysers as a true third-party control.