HardyDisk AST Cefiderocol 30µg (FDC30)

HardyDisk AST Cefiderocol 30µg (FDC30) is an FDA 510(k)-cleared medical device (K253105) 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 November 19, 2025. Regulation: 8.