Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems is an FDA 510(k)-cleared medical device (K222638) manufactured by Cepheid. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 26, 2023. Regulation: 8.