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(a) Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
(b) Classification. Class II.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.862.1110 Bilirubin (total or direct) test system - last updated October 03, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-862-1110.html
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