Glossary Term
A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis.
Regulatory Definitions
Tests
Bilirubin is in the insoluble form, unconjugated bilirubin (indirect bilirubin).The non-water soluble, free bilirubin does not react with sulfanilic acid at acidic pH to produce a red colored complex until an accelearator, alcohol, is added to the solution to perform a quantitative measurement of unconjugated bilirubin levels.
For professionals