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Medical Devices / Submissions and Approvals

GenMark Gains 510(k) Clearance for Fungal Pathogen Panel

Dec. 27, 2018

The FDA granted GenMark Diagnostics clearance to market its ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) panel, used to diagnose infections in the bloodstream that can cause sepsis.

The panel can detect emerging, resistant strains such as Candida auris, which can be difficult to identify through standard laboratory methods.

The ePlex systems use disposable test cartridges and are approved to test for various infectious diseases, including gastrointestinal and respiratory infections.

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