Idaho files for FDA clearance of expanded FilmArray respiratory panel
Idaho Technology has filed for FDA 510(k) clearance of five additional respiratory pathogens for its FilmArray respiratory panel.
FilmArray respiratory panel is a Multiplex PCR assay currently FDA cleared for 15 respiratory pathogens.
The additional five pathogens for which the company filed are Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43.
Idaho CEO Kirk Ririe said that many of their potential and current hospital laboratory customers are anticipating the launch of the expanded FilmArray respiratory panel.
"We are very excited about the potential addition of these five respiratory pathogens - particularly the bacterial targets," Ririe added.
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