The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.

The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Assay when processing 24–36 samples. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis.

The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis Clinical Sequencing Assay is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035429 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1/515038248 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1A15038249 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1B15035436 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 2/515035430 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3/515038250 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3A 15038251 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3B15036622 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 4/515036623 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 5/5