ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel is an FDA 510(k)-cleared medical device (K181663) manufactured by Genmark Diagnostics, Incorporated. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2018. Regulation: 8.