LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is an FDA 510(k)-cleared medical device (K211815) manufactured by Affinity Biosensors. 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 1, 2024. Regulation: 8.