CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Feb. 8, 2023—BioMérieux has received FDA 510(k) clearance and a CLIA waiver for its BioFire SpotFire system and BioFire SpotFire respiratory panel. The system has a footprint of approximately the size of a standard sheet of paper, the company says, and is scalable up to four modules. Results are available in about 15 minutes. The panel detects 15 common bacteria, viruses, and viral subtypes that cause respiratory tract infections.
BioMérieux has also developed the BioFire SpotFire R Panel Mini, which is intended to detect five common viruses—SARS-CoV-2, influenza A and B, respiratory syncytial virus, and rhinovirus. The company plans to submit a 510(k) for the R Panel Mini by the end of the first quarter.
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