QUANTA LITE LYME IGM ELISA

QUANTA LITE LYME IGM ELISA is an FDA 510(k)-cleared medical device (K984234) 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 April 14, 1999. Regulation: 8.