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.

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 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 consisting of the individual boxes listed below, which are all labeled with the same Device Identifier:20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3.

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 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 (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 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.

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.

For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].

For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].

For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.

For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP).

For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.

For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.

For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.

For the quantitative determination of human 3rd complement component (Complement C3) in serum by immunoturbidimetric assay.

For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay.

For the calibration of the K-ASSAY® CRP assay.

For the quantitative determination of human IgA in serum by immunoturbidimetric assay.

For the quantitative determination of human IgG in serum by immunoturbidimetric assay.

For the quantitative determination of human IgM in serum by immunoturbidimetric assay.

For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.

For the quantitative determination of human albumin in urine by immunoturbidimetric assay.

For the quantitative determination of human alpha-1 acid glycoprotein (Alpha-1 AG) in serum by immunoturbidimetric assay.

For the quantitative determination of human haptoglobin in serum by immunoturbidimetric assay.

For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.

For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.

For the quantitative determination of human C-reactive protein (CRP) in serum by immunoturbidimetric assay.

For the quantitative determination of human rheumatoid factor (RF) in serum by immunoturbidimetric assay.

For the calibration of the K-ASSAY® RF assay.

For the quantitative determination of human C-reactive protein (CRP) in serum by immunoturbidimetric assay.

For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.

For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay.

For the quantitative determination of human prealbumin in serum by immunoturbidimetric assay.

For the calibration of the K-ASSAY® Prealbumin assay.

For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric assay.

For the quantitative determination of human albumin in urine by immunoturbidimetric assay.

For the calibration of the K-ASSAY® Alpha-1 Microglobulin assay.

For the calibration of the K-ASSAY® Alpha-1 Microglobulin assay.

For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.

For the calibration of the K-ASSAY® CRP (3) assay.

For the calibration of the K-ASSAY® CRP (3) assay.

For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.

For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay.

For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.

For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.

For the calibration of the K-ASSAY® Factor XIII assay.

For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.

For the quantitative determination of human coagulation factor XIII in plasma.

For the calibration of the K-ASSAY® Factor XIII assay.