Great Basin Stool Bacterial Pathogens Panel

Great Basin Stool Bacterial Pathogens Panel is an FDA 510(k)-cleared medical device (K163571) manufactured by Great Basin Scientific, 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 July 11, 2017. Regulation: 8.