ADVIA CENTAUR HAVM ASSAY

ADVIA CENTAUR HAVM ASSAY is an FDA 510(k)-cleared medical device (K081716) 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 16, 2008. Regulation: 8.