BioFire Files 510(k) Submission to FDA for Blood Culture Panel | GenomeWeb

NEW YORK (GenomeWeb News) – BioFire Diagnostics today announced the 510(k) submission of its FilmArray Blood Culture Identification, or BCID, Panel to the US Food and Drug Administration.

The submission follows the successful completion of clinical trials for the panel, which provides automatic results for the most common infectious causes of sepsis. BioFire said that pending clearance from FDA, it anticipates launching the panel in the summer.

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