ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel is an FDA 510(k)-cleared medical device (K213236) 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 April 26, 2022. Regulation: 8.