BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel.
The BCID panel provides automatic results for the most common infectious causes of sepsis and simultaneously tests positive blood cultures for approximately 90% of the gram-positive bacteria, gram-negative bacteria and yeast microbes that cause bloodstream infections.
BioFire Diagnostics CEO Kirk Ririe said that the submission of the BCID panel to the FDA marks another milestone in expanding the menu of tests for the FilmArray platform.
BioFire may commercially release the panel in summer 2013, pending FDA clearance.
Source:
http://drugdelivery.pharmaceutical-business-review.com/news/biofire-seeks-fda-approval-for-filmarray-blood-culture-identification-test-170413
