BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST is an FDA 510(k)-cleared medical device (K991074) manufactured by Intracel 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 December 20, 1999. Regulation: 8.