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Medical Devices / Submissions and Approvals

BioFire Diagnostics’ Pneumonia Panels Cleared by FDA

Nov. 15, 2018

The FDA has granted 510(k) clearance for BioMérieux affiliate BioFire Diagnostics’ panel assay for detecting lower respiratory tract infections.

The PCR-based panels are able to distinguish between 33 common pathogens that cause pneumonia. A version of the panel featuring an extra target has also received the CE Mark.

The panels, which give test results in approximately one hour, have been cleared for use with sputum and bronchoalveolar lavage samples.

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