LEGIONELLA INDIRECT FLUORESCENT ANTIBOD

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD is an FDA 510(k)-cleared medical device (K832896) manufactured by Biodan Medical Systems, Ltd.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 1983. Regulation: 8.