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 Siemens Healthcare Diagnostics, Inc..
List of Diazo Colorimetry, Bilirubin devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Diazo Colorimetry, Bilirubin devices (product code CIG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →