QUANTA LITE REBELLA IGG

QUANTA LITE REBELLA IGG is an FDA 510(k)-cleared medical device (K971304) 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 1, 1998. Regulation: 8.