The TruSight Cystic Fibrosis Library Prep™ is a library preparation kit that supports the TruSight CysticFibrosis 139-Variant Assay™ and the TruSight Cystic Fibrosis Clinical Sequencing Assay™.The TruSight Cystic Fibrosis Library Preparation is an IVD kit constisting of the individual boxes listed below, which are all labeled with the same Device Identifier:20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035691, TruSight™ Cystic Fibrosis Library Prep 1A;20035692, TruSight™ Cystic Fibrosis Library Prep 1B; 20035693, TruSight™ Cystic Fibrosis Library Prep 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep 3/3;20035695, TruSight™ Cystic Fibrosis Library Prep 3A;20035696, TruSight™ Cystic Fibrosis Library Prep 3B.

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier:15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/515041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/515041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/515041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/515041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5