BOSTON, Nov. 14 -- PerkinElmer Inc., the leading provider of solutions to newborn screening laboratories, said it is the first company to receive FDA 510(k) clearance to market a comprehensive screening system to identify whether a newborn may become developmentally impaired or risk premature death. PerkinElmer's NeoGram Phenylalanine Test System, consisting of a reagent kit, application software and tandem mass spectrometer, will be used to identify a disorder known as phenylketonuria (PKU) in newborns.
The reagent kit is designed to run exclusively on tandem mass spectrometry equipment, a new technology for newborn screening, PerkinElmer said.
For more information, visit: lifesciences.perkinelmer.com