ADVIA Centaur® Total hCG assay

ADVIA Centaur® Total hCG assay is an FDA 510(k)-cleared medical device (K200210) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2021. Regulation: 8.