Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 is an FDA 510(k)-cleared medical device (K160729) manufactured by Roche 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 June 12, 2016. Regulation: 8.