Luminex Strep Assay Wins FDA Clearance

Texas-based Luminex received 510(k) marketing clearance for its ARIES Group A strep assay.

The assay was designed for directly detecting Steptococcus pyogenes using throat swab specimens.

The strep assay is the sixth to receive FDA clearance for use in the ARIES system over the last 24 months, the company said.