
Siemens Healthcare Diagnostics, Inc.
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ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is an FDA 510(k)-cleared medical device (K170065) 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 March 8, 2017. Regulation: 8.