Cepheid Xpert GBS LB Control Panel

Cepheid Xpert GBS LB Control Panel is an FDA 510(k)-cleared medical device (K182472) manufactured by Microbiologics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2018. Regulation: 8.