Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL is an FDA 510(k)-cleared medical device (K221198) 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 March 9, 2023. Regulation: 8.