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NEW YORK (GenomeWeb) – BioMérieux today said that the US Food and Drug Administration has given 510(k) clearance to its BioFire Diagnostics business for the FilmArray Respiratory Panel 2 (RP2), which tests for 17 viruses and four bacteria that are responsible for respiratory tract infections.

The panel will be commercially available in the US by mid-June, the firm said.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.