Sanger sequencing system and HLA typing kits, 9/13
Life Technologies in February received FDA 510(k) clearance for its 3500 Dx genetic analyzers and SeCore HLA typing kits. The company’s 7500 Fast Dx real-time PCR system was cleared for diagnostic use with the CDC’s H1N1 assay in 2008. The Applied Biosystems 3500 Dx/3500xL Dx CS2 genetic analyzers, Invitrogen SeCore HLA sequencing kits, and uType Dx HLA sequence analysis software constitute the first FDA 510(k)-cleared sequence-based system for HLA typing in the United States. HLA typing on the 3500 Dx