ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM is an FDA 510(k)-cleared medical device (K142133) manufactured by Roche Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2014. Regulation: 8.