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Tag Archives: GenMark Diagnostics—

GenMark’s IVD platform gets 510(k) clearance

June 13, 2017—GenMark Diagnostics has received 510(k) market clearance from the Food and Drug Administration for its ePlex instrument and its Respiratory Pathogen (RP) Panel. Eplex is a new in vitro diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into a fully automated, sample-to-answer system. Rapid and highly specific detection is enabled on ePlex by GenMark’s eSensor ...

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