BINAX LEGIONELLA URINARY ANTIGEN EIA

BINAX LEGIONELLA URINARY ANTIGEN EIA is an FDA 510(k)-cleared medical device (K934965) manufactured by Binax, 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 September 19, 1994. Regulation: 8.