LEGIONELLA CULTURE CONFIRMATIN KIT

LEGIONELLA CULTURE CONFIRMATIN KIT is an FDA 510(k)-cleared medical device (K851271) manufactured by Gen-Probe, 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 7, 1985. Regulation: 8.