The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL is an FDA 510(k)-cleared medical device (K231433) manufactured by Thermo Fisher Scientific. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2023. Regulation: 8.