BioFire Receives FDA 510(k) Clearance for FilmArray® Torch with FilmArray® Respiratory Panel and Submits Special 510(k) Applications for Use with additional FilmArray® Panels
Submitted by kBLASTER Team on
by Business Wire
MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has received Special 510(k)1 clearance from the U.S. Food and Drug Administration (FDA) to market the FilmArray® Torch for use with the FilmArray...