Address:5200 Illumina Way,San Diego,CA,92122,US
Device Description : The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signa 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.
Device Class : 2
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library prepa 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
Device Class : 2
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of libra 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
Device Class : 2
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library prepa 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.
Device Class :
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the p 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
Device Class : 1
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The MiSeqDx Reagent Kit v3 uses libraries prepared from DNA where sample indexes 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
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Praxis™ Extended RAS Panel assay is designed specifically for the detection 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.
Device Class : 3
Duns Number: 033305264
Premarket Exempt : No
Prescription Use : Yes
Device Description : The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for seque 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.
Device Class : 1
Duns Number: 033305264
Premarket Exempt : Yes
Prescription Use : Yes