ADVIA Centaur® Digoxin assay

ADVIA Centaur® Digoxin assay is an FDA 510(k)-cleared medical device (K193397) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2021. Regulation: 8.