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Life Technologies Receives FDA 510(k) Clearance for Diagnostic Use of Sanger Sequencing Platform and HLA Typing Kits
Date:2/11/2013

laboratory in mind, featuring a novel design that incorporates the ability to track patient samples with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software."

Products included in the current 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 (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.

Additional products offered by Life Technologies for the diagnostics lab market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument, which is CE-IVD marked for use in Europe and under review by FDA; the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool is available for assisting in the validation and verificat
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SOURCE Life Technologies Corporation
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