Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL is an FDA 510(k)-cleared medical device (K182797) 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 November 29, 2018. Regulation: 8.