VITROS BRAHMS PCT Reagent Pack and Calibrators

VITROS BRAHMS PCT Reagent Pack and Calibrators is an FDA 510(k)-cleared medical device (K200236) manufactured by Ortho Clinical Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2020. Regulation: 8.