June 2019—GenMark Diagnostics received FDA 510(k) clearance for its ePlex Blood Culture Identification Gram-Negative Panel. The panel is for use on the company’s ePlex system for the diagnosis and disease management of bloodstream infections that can lead to sepsis. Two other FDA-cleared BCID panels are available on the system—the gram-positive panel and fungal pathogen panel.
GenMark Diagnostics, 760-448-4300