Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is an FDA 510(k)-cleared medical device (K181599) manufactured by Beckman Coulter. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2019. Regulation: 8.