COBAS INTEGRA BILIRUBIN DIRECT GEN.2

COBAS INTEGRA BILIRUBIN DIRECT GEN.2 is an FDA 510(k)-cleared medical device (K123965) manufactured by Roche Diagnostics. 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 February 27, 2013. Regulation: 8.