The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. Instrument software performs image analysis and base calling, assigning a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis processes base calls on the instrument. The NextSeq 550Dx instrument uses different secondary analysis modules depending on the workflow. For the germline or somatic variant calling modules, data processing includes de-multiplexing, FASTQ file generation, alignment, variant calling, and generation of variant call format (VCF) files containing information regarding variants found at specific positions in a reference genome.

DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.

DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.

The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run.Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.

The MiSeqDx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands.The Illumina MiSeqDx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeqDx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method.The MiSeqDx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier:20011196, MiSeqDx Reagent Kit v3, 1/2;20011197, iSeqDx Reagent Kit v3, 2/2

The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle.The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.

The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the NextSeq 550Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier:20019558, NextSeq™ 550Dx Accessory Box – 300 cycles;20019557, NextSeq™ 550Dx High Output Flow Cell Cartridge v2, 300 cycles;20019555, NextSeq™ 550Dx, High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles.

The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.

The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is a single-use set of reagents and consumables for sequencing on the NextSeq™ 550Dx instrument. For its input, the NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) uses libraries generated from DNA where sample indexes and capture sequences are addedto amplified targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect fluorescently-labeled single nucleotide bases as they are incorporated into growing DNA strands.The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019555, NextSeq™ 550Dx High Output Reagent Cartridge v2, 300 cycles;20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles;20026365, NextSeq™ 550Dx High Output Flow Cell Cartridge v2.5, 300 cycles;20019558, NextSeq™ 550Dx Accessory Box – 300 cycles.

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 MiSeq™ Dx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands.The Illumina MiSeq™ Dx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeq™ Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method.The MiSeq™ Dx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier:20036261, MiSeqDx Reagent Kit v3, 1/2;20036262, MiSeqDx Reagent Kit v3, 2/2

The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq™ 6000Dx Instrument. The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) use libraries generated using validated assays. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing DNA strands. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier:20046934, NovaSeq™ 6000Dx S2 Cluster Cartridge; 20046936, NovaSeq™ 6000Dx S2 SBS Cartridge; and 20045447, NovaSeq™ 6000Dx S2 Flow Cell.

The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq 6000Dx Instrument. The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) use libraries generated using validated assays. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing DNA strands. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20046938, NovaSeq™ 6000Dx S4 Cluster Cartridge; 20046940, NovaSeq™ 6000Dx S4 SBS Cartridge; and 20045448, NovaSeq™ 6000Dx S4 Flow Cell.

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems.The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier. 20050025, Illumina® Prep Dx Tagmentation Reagents 1; 20050026, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050027, Illumina® Prep Dx Tagmentation Reagents 3; 20050028, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050029, Illumina® DNA Prep Dx Enrichment Reagents 2; 20050030, Illumina® Prep Dx Cleanup Beads; and 20050038, Illumina® Unique Dual Index Dx Set A (96 Indexes).

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems.The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier. 20050025, Illumina® Prep Dx Tagmentation Reagents 1; 20050026, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050027, Illumina® Prep Dx Tagmentation Reagents 3; 20050028, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050029, Illumina® DNA Prep Dx Enrichment Reagents 2; 20050030, Illumina® Prep Dx Cleanup Beads; and 20050039, Illumina® Unique Dual Index Dx Set B (96 Indexes).

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems.The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20050020, Illumina® Prep Dx Tagmentation Reagents 1; 20050021, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050022, Illumina® Prep Dx Tagmentation Reagents 3; 20050023, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050024, Illumina® DNA Prep Dx Enrichment Reagents 2; and 20050038, Illumina® Unique Dual Index Dx Set A (96 Indexes).

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems.The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20050020, Illumina® Prep Dx Tagmentation Reagents 1; 20050021, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050022, Illumina® Prep Dx Tagmentation Reagents 3; 20050023, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050024, Illumina® DNA Prep Dx Enrichment Reagents 2; and 20050039, Illumina® Unique Dual Index Dx Set B (96 Indexes).

The Illumina NovaSeq™ 6000Dx Library Tube is intended to hold sample libraries for sequencing with NovaSeq 6000Dx S2 or S4 reagent kits and validated assays. The tube is boxed in one box, 20046942, NovaSeq™ 6000Dx Library Tube, which is labeled with the same Device Identifier.

The Illumina NovaSeq™ 6000Dx Library Tubes, 24 pack are intended to hold sample libraries for sequencing with NovaSeq™ 6000Dx S2 or S4 reagent kits and validated assays. The tubes are boxed together in one box, 20060177, NovaSeq™ 6000Dx Library Tubes Pk, which is labeled with the same Device Identifier.

The NovaSeq™ 6000Dx S2 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the Cartridge. The set is boxed together in one box 20046945, NovaSeq™ 6000Dx S2 Buffer Cartridge, which is labeled with the same Device Identifier.

The NovaSeq™ 6000Dx S4 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the cartridge. The set is boxed together in one box, 20046947, NovaSeq™ 6000Dx S4 Buffer Cartridge, which is labeled with the same Device Identifier.

The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and primary analysis on the MiSeq™Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface.

The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, and primary analysis on the NextSeq™ 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay.The LRM software (SW) includes the UDI information in the User Interface.

The MiSeq™Dx Reagent Kit v3 Micro uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Illumina MiSeq™ Dx Reagent Kit v3 Micro is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeq™Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeq™Dx Reagent Kit v3 Micro is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20064640, MiSeqDx Reagent Kit v3 Micro, 1/2; 20064641, MiSeqDx Reagent Kit v3 Micro, 2/2

The NovaSeq™ 6000Dx Instrument is intended for sequencing DNA libraries with in vitro diagnostic assays. For its input, the NovaSeq™ 6000Dx uses libraries generated from DNA where sample indexes and capture sequences are added to amplified targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling and assigns a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis can be executed on the included and required Illumina DRAGEN Server for NovaSeq™ 6000Dx to process base calls. The NovaSeq™ 6000Dx uses different secondary analysis applications depending on the workflow.

The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, run monitoring, primary and secondary analysis on the NovaSeq™ 6000Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The software (SW) includes the UDI information in the User Interface.

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

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 (20 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035471 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/515038252, MiSeqDx Cystic Fibrosis 139 Variant Assay 1A; 15038253, MiSeqDx Cystic Fibrosis 139 Variant Assay 1B; 15035478, MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5; 15035472, MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5; 15038254, MiSeqDx Cystic Fibrosis 139 Variant Assay 3A; 15038255, MiSeqDx Cystic Fibrosis 139 Variant Assay 3B; 15036624, MiSeqDx Cystic Fibrosis 139 Variant Assay 4/5; 15038119, MiSeqDx Cystic Fibrosis 139 Variant Assay 5/5.

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

The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/515039485 MiSeqDx Universal Kit 1.0 1A15039488 MiSeqDx Universal Kit 1.0 1B15039492 MiSeqDx Universal Kit 1.0 2/515039498 MiSeqDx Universal Kit 1.0 3/515039494 MiSeqDx Universal Kit 1.0 3A15039496 MiSeqDx Universal Kit 1.0 3B15039500 MiSeqDx Universal Kit 1.0 4/515039503 MiSeqDx Universal Kit 1.0 5/5

The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through theuse of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysissoftware.