Atellica® CH Diazo Direct Bilirubin (D_DBil)

Atellica® CH Diazo Direct Bilirubin (D_DBil) is an FDA 510(k)-cleared medical device (K223078) 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 June 11, 2023. Regulation: 8.