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Sanger sequencing system and HLA typing kits, 9/13

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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 offers labs an optimized, streamlined workflow with high resolution.

“Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab,” Ronnie Andrews, president of medical sciences at Life Technologies, said in a statement. The instrument was designed with the clinical laboratory in mind and its design incorporates the ability to track reagent usage with radio frequency identification tags, as well as redesigned data collection and analysis software, Andrews said.

Products included in the 510(k) clearance are the 3500 Dx/3500xL Dx genetic analyzers CS2; 3500 Dx series data collection software v1.0; SeCore HLA sequencing kits; and uType Dx HLA sequence analysis software. The 3500 Dx instrument is CE-Marked for in vitro diagnostic use in Europe; has been approved by China’s State Food and Drug Administration for diagnostic use in China; and is available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.

Life Technologies, 800-955-6288

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