ADVIA Centaur HAV IgM Assay

ADVIA Centaur HAV IgM Assay is an FDA 510(k)-cleared medical device (K161964) 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 October 12, 2016. Regulation: 8.