IQ/QCA TOTAL BILIRUBIN

IQ/QCA TOTAL BILIRUBIN is an FDA 510(k)-cleared medical device (K874261) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 November 24, 1987. Regulation: 8.