The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL is an FDA 510(k)-cleared medical device (K243738) 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 February 26, 2025. Regulation: 8.