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Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2

BioFire Diagnostics, LLC · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.
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