ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is an FDA 510(k)-cleared medical device (K181082) 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 May 24, 2018. Regulation: 8.