ADVIA Centaur Enhanced Liver Fibrosis (ELF)

ADVIA Centaur Enhanced Liver Fibrosis (ELF) is an FDA 510(k)-cleared medical device (DEN190056) 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 August 19, 2021. Regulation: 8.