ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is an FDA 510(k)-cleared medical device (K182690) 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 20, 2018. Regulation: 8.