With 510(k) Clearance for 3500 Dx, Life Tech Aims to Convert HLA Typing Customers to Cleared Box, Assay | GenomeWeb

Life Technologies said this week that the US Food and Drug Administration has cleared its SeCore HLA typing assay and its 3500 Dx Genetic Analyzer, a Sanger sequencing instrument, for diagnostic use. The 510(k) clearance is a first for a sequencing system and sequencing-based assay, and the company's president of medical sciences, Ronnie Andrews, said that it "validates Life's move into diagnostics" as the company aims to bring additional products, such as its QuantStudio Dx real-time PCR system and Ion Torrent PGM, through 510(k) clearance.

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