VIDAS B.R.A.H.M.S. PCT (PCT)

VIDAS B.R.A.H.M.S. PCT (PCT) is an FDA 510(k)-cleared medical device (K160911) manufactured by bioMerieux, Inc.. 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 27, 2016. Regulation: 8.