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Tag Archives: GenMark Diagnostics—

FDA clears two ePlex blood culture identification panels

Dec. 28, 2018—GenMark Diagnostics has received FDA 510(k) market clearance for its ePlex Blood Culture Identification Fungal Pathogen Panel. This panel, together with the ePlex Blood Culture Identification Gram-Positive Panel, which received FDA clearance Dec. 20, and Gram-Negative Panel were developed for the diagnosis and disease management of bloodstream infections that can lead to sepsis. “Receiving FDA clearance for two of our ...

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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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