QUANTA LITE CMV IGG ELISA

QUANTA LITE CMV IGG ELISA is an FDA 510(k)-cleared medical device (K971335) 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 November 30, 1997. Regulation: 8.