GI panel submitted for 510(k) clearance, 5/14

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May 2014—BioFire Diagnostics submitted the Film­Array Gastrointestinal Panel to the FDA for 510(k) clearance. The panel, which tests for more than 20 common bacteria, viruses, and parasites that cause infectious diarrhea, was submitted after successfully completing a clinical study that included more than 1,500 prospective samples.

BioFire Diagnostics, 801-736-6354