PerkinElmer GSP cleared for newborn screening
This article was originally published in The Gray Sheet
Executive Summary
Firm's automated GSP Genetic Screening Processor gains 510(k) clearance, the firm announces Nov. 3. The device, which also earned a CE mark in January, runs many blood samples simultaneously to screen newborn infants for a range of genetic, metabolic or hematological disorders. While the GSP Neonatal TSH thyroid stimulating hormone assay is the first to receive FDA clearance for use on the GSP instrument, several additional newborn screening assays are in development, the firm says