ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY is an FDA 510(k)-cleared medical device (K131605) 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 February 27, 2014. Regulation: 8.