Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL is an FDA 510(k)-cleared medical device (K231994) 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 24, 2023. Regulation: 8.