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The lon PGM™ Dx Instrument System is intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The lon PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing.

The Ion PGM™ Dx System is used for detection of human variant sequences from DNA from whole blood samples or RNA and DNA from FFPE tissue samples. Detectable variants include substitutions, insertions, and deletions. The Ion PGMTM Dx System consists of the following: - Ion OneTouch™ Dx Instrument - Ion OneTouch™ ES Dx Instrument - Ion OneTouch™ Rack Kit - Ion PGM™ Dx Chip Minifuge - Ion PGM™ Dx Sequencer - Ion PGMTM Wireless Scanner - DynaMag™ Dx Kit—Tube & Plate - Ion Torrent™ Server - Torrent Suite™ Dx Software The Ion PGM™ Dx System is used in conjunction with the following kits: - Ion PGM™ Dx Library Kit - Ion OneTouch™ Dx Template Kit - Ion PGM™ Dx Sequencing Kit - Ion 318™ Dx Chip Kit The system should be used only by professionals trained in laboratory techniques and procedures and in the use of the system.

The MiSeqDx Platform is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples. The MiSeqDx Platform is not intended for whole genome or de novo sequencing.

The MiSeqDx Platform is a high throughput DNA sequence analyzer for clinical use. The MiSeqDx Platform consists of the MiSeqDx instrument and data analysis software. It is for use with the MiSeqDx Universal Kit 1.0 [MiSeqDx reagent cartridge, MiSeqDx flow cell, SBS Solution (PR2 buffer)] for library preparation and sample indexing (k133136). The end-user inputs extracted genomic DNA to be sequenced and provides the Analyte Specific Reagents (ASRs) to develop a sequencing assay that targets their sequence of interest.