CYTOMEGALOVIRUS IGG EIA TEST KIT

CYTOMEGALOVIRUS IGG EIA TEST KIT is an FDA 510(k)-cleared medical device (K843189) manufactured by Labsystems, 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 7, 1986. Regulation: 8.