Address:5200 Illumina Way,San Diego,CA,92122,US
Device Description : The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is a single-use set 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries p 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.
Device Class : 2
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The TruSight Cystic Fibrosis Library Prep™ is a library preparation kit that sup 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.
Device Class : 2
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MiSeq™ Dx Reagent Kit v3 uses libraries prepared from DNA where sample index 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
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumabl 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).
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumabl 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).
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumabl 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).
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumabl 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).
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) is single-use sets of reage 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes