FDA Product Code CIG: Diazo Colorimetry, Bilirubin

Bilirubin measurement is essential in neonatal jaundice management and liver disease evaluation. FDA product code CIG covers diazo colorimetric systems for bilirubin quantification.

The diazo reaction produces a colored azobilirubin complex proportional to bilirubin concentration in serum, enabling measurement of total and direct bilirubin for the assessment of jaundice, hepatitis, and biliary obstruction.

CIG devices are Class II medical devices, regulated under 21 CFR 862.1110 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Roche Diagnostic Systems, Inc..