Selux AST System; Model AST Gen 1.0

Selux AST System; Model AST Gen 1.0 is an FDA 510(k)-cleared medical device (K211748) manufactured by Selux Diagnostics, 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 April 18, 2023. Regulation: 8.