FDA greenlights BioMérieux's mini respiratory, sore throat panel for POC testing

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BioMérieux received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini respiratory viral and bacterial testing device designed for point-of-care (POC) testing.

The small multiplex R/ST Panel Mini is identical to the larger existing R/ST panel, except that the Mini uses modified labeling and modified software to report only five of the 15 targets on the respiratory menu and five from the sore throat menu, according to BioMérieux. The Mini is compatible with the Biofire Spotfire System and provides a Clinical Laboratory Improvement Amendments (CLIA)-waived testing option.

Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini analyzes samples taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected. The Biofire Spotfire R/ST Panel Mini becomes the fourth to be FDA-cleared and CLIA-waived, BioMérieux said.

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