ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is an FDA 510(k)-cleared medical device (K181213) manufactured by Siemens Healthcare 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 July 29, 2018. Regulation: 8.