GENETIC SYS LEGIONELLA IMMUNOFLURORES

GENETIC SYS LEGIONELLA IMMUNOFLURORES is an FDA 510(k)-cleared medical device (K842683) manufactured by Genetic Systems Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 1984. Regulation: 8.