ADVIA Centaur Anti-Thyroglobulin II (aTgII)

ADVIA Centaur Anti-Thyroglobulin II (aTgII) is an FDA 510(k)-cleared medical device (K250816) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2025. Regulation: 8.