Thermo Scientific Sensititre ARIS HiQ System

Thermo Scientific Sensititre ARIS HiQ System is an FDA 510(k)-cleared medical device (K191918) 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 5, 2019. Regulation: 8.