A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.
A collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen, using an enzyme spectrophotometry method.
A collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen, using a spectrophotometry method.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of conjugated (direct) bilirubin in a clinical specimen, using a spectrophotometry method.
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of conjugated (direct) bilirubin in a clinical specimen.
A noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the fo...
A mains electricity (AC-powered) laboratory instrument designed to determine, by direct or indirect measurement, the concentration of bilirubin in the blood or other clinical specimen most commonly to rapidly assess hyperbilirubinemia in neonates. It typica...