Spotfire R/ST Panel Mini gets special 510(k) clearance

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June 27, 2024—BioMérieux announced that its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini has received FDA special 510(k) clearance and CLIA waiver.

The R/ST Panel Mini is a multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in about 15 minutes on the Biofire Spotfire system. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or a throat swab when pharyngitis is suspected.