Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL is an FDA 510(k)-cleared medical device (K181946) 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 7, 2018. Regulation: 8.