Simplexa GBS Direct, Simplexa GBS Positive Control Pack

Simplexa GBS Direct, Simplexa GBS Positive Control Pack is an FDA 510(k)-cleared medical device (K182467) manufactured by Diasorin Molecular, LLC. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 6, 2018. Regulation: 8.