Ion Torrent Genexus Dx integrated sequencer
Harness the power of NGS for your clinical lab with a fast, flexible, automated CE-marked IVD system.
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Designed to make next-generation sequencing (NGS) accessible to clinical laboratories with all levels of sequencing expertise, the Ion Torrent Genexus Dx Integrated Sequencer delivers an effortless user experience while enabling regulatory compliance.
Intended Use: The Ion Torrent Genexus Dx Integrated Sequencer is an in vitro diagnostic (IVD) medical device intended to be used by trained personnel in a professional laboratory environment for automated, qualitative targeted sequencing of human DNA or RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples or plasma samples. The Ion Torrent Genexus Dx System consists of the Ion Torrent Genexus Dx Integrated Sequencer, and the Ion Torrent Genexus Dx Software.
Features:
- Stringent performance characteristics to enable diagnostic use
- Developed under design control principles, manufactured in facilities regulated by FDA, ISO13485 certified, manufactured under Current Good Manufacturing Practices (cGMPs)
- Perform IVD assays and conduct clinical research on the same instrument
- All research assays and applications performed on the RUO Genexus Integrated Sequencer can be performed on Genexus Dx Integrated Sequencer
- Rapidly go from nucleic acid to report in as little as 24 hours
- Reduce NGS operating costs with simplified setup using pre-filled reagents
