LEGIONELLA STAT IGG/IGM TEST KIT

LEGIONELLA STAT IGG/IGM TEST KIT is an FDA 510(k)-cleared medical device (K911356) manufactured by Whittaker Bioproducts, 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 July 29, 1992. Regulation: 8.