ADVIA Centaur Total IgE (tIgE)

ADVIA Centaur Total IgE (tIgE) is an FDA 510(k)-cleared medical device (K193493) 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 January 14, 2020. Regulation: 8.