BioFire Diagnostics, Inc Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test
Published: Apr 17, 2013
SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc. today announced that it has submitted the FilmArray Blood Culture Identification (BCID) Panel to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The submission comes after the successful completion of clinical trials for the FilmArray BCID Panel. The panel provides automatic results for the most common infectious causes of sepsis, a significant cause of mortality and morbidity in adults, children and infants. BioFire anticipates commercial release of the panel in summer 2013, pending FDA clearance.