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Medical Devices / Submissions and Approvals

BioMérieux Wins FDA Clearance for BioFire’s FilmArray Respiratory Panel 2

June 2, 2017
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BioFire Diagnostics, affiliate to bioMérieux, has received FDA marketing clearance for the FilmArray Respiratory Panel 2.

The RP2 tests for 21 pathogens (17 viruses and 4 bacteria) responsible for respiratory tract infections.

The FilmArray RP2 advances the existing FilmArray respiratory panel by reducing the assay time from an hour to less than 45 minutes.

The test and will be available mid-June 2017. — Cynthia Jessup

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