DIRECT FA CONJUGATE FOR LEGIONELLA SPP

DIRECT FA CONJUGATE FOR LEGIONELLA SPP is an FDA 510(k)-cleared medical device (K822859) manufactured by Zeus Technologies. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 1983. Regulation: 8.