DIRECT FA CONJUGATE FOR LEGIONELLA SP

DIRECT FA CONJUGATE FOR LEGIONELLA SP is an FDA 510(k)-cleared medical device (K813339) manufactured by Springwood Microbiologicals. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 1981. Regulation: 8.