Zdrowie i gospodarka · 24/11/2004

FDA Publishes Guidance for Newborn Screening Test Systems Using Tandem Mass Spectrometry

The Food and Drug Administration (FDA) has released a guidance document outlining requirements for newborn screening test systems that use tandem mass spectrometry to analyze amino acids, free carnitine, and acylcarnitines, which is now in effect as a special control for class II devices.