Microbial-isolate identification and testing IVDs

Intended purpose

The MBT STAR-BL product family kits are qualitative in vitro diagnostic medical devices indicated for use in conjunction with other clinical and laboratory findings to aid the rapid detection of a prevalent β-lactamase activity towards selected microorganisms subcultured from human specimens using a benchmark antibiotic. Analysis utilizes MALDI TOF (Matrix-Assisted Laser Desorption/Ionization-Time of Flight)-based IVD MALDI Biotyper System and the MBT STAR-BL IVD Module.