QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT is an FDA 510(k)-cleared medical device (K994004) manufactured by Inova Diagnostics, 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 January 26, 2000. Regulation: 8.