Idaho Technology Inc. Submits FilmArray(R) Respiratory Panel to FDA for 510(k) Clearance
11/4/2010 8:55:48 AM
SALT LAKE CITY--(BUSINESS WIRE)--Idaho Technology, Inc. (ITI) announced today that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance to market its FilmArray Respiratory Panel (RP) as an in vitro diagnostic product for patients with symptoms of upper respiratory tract infection. The FilmArray RP is a user-friendly multiplex PCR assay designed for the detection and differentiation of a panel of respiratory viruses and bacteria including: adenovirus, bocavirus, corona viruses, human metapneumovirus, influenza A and B viruses, parainfluenza viruses, rhino/entero viruses, respiratory syncytial virus, Bordetella pertussis, and Mycoplasma pneumoniae.
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