HardyDisk AST Omadacycline 30µg (OMC30)

HardyDisk AST Omadacycline 30µg (OMC30) is an FDA 510(k)-cleared medical device (K183298) manufactured by Hardy Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 2019. Regulation: 8.