Bedford, Massachusetts-based Instrumentation Laboratory has announced FDA clearance for a new assay which can measure bilirubin concentration (tBili) in newborn babies. Bilirubin is naturally produced in newborns as fetal blood cells are broken down, but abnormally high concentrations can result in permanent brain damage. The tBili assay will be performed using the company’s GEM Premier 4000 analyzer, which will provide results in 90 seconds.
From the press release:
tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy. Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status.
Press release: Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer…
Product page: GEM Premier 4000…