GenMark Diagnostics Submits Respiratory Viral Panel Test for FDA 510(k) Clearance
Published: Dec 22, 2011
CARLSBAD, Calif.--(BUSINESS WIRE)--GenMark Diagnostics, Inc., (NASDAQ: GNMK) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, a Respiratory Viral Panel for use on its eSensor® XT-8 system. The test is designed to identify multiple viruses from individuals exhibiting signs and symptoms of respiratory infection. The eSensor Respiratory Viral Panel is designed to be a fast, easy-to-use molecular diagnostic test to provide accurate results while requiring less technologist time.