DYNEX SmartPLEX MMRV IgG Assay Kit

DYNEX SmartPLEX MMRV IgG Assay Kit is an FDA 510(k)-cleared medical device (K212769) manufactured by Dynex Technologies, 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 September 28, 2023. Regulation: 8.