NextSeq 550Dx Sequencing System

Primary DI
00816270020125
Brand
NextSeq 550Dx Sequencing System
Company
ILLUMINA, INC.
Model
20005715
Catalog number
20005715
Device description
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.
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PFFHigh Throughput Dna Sequence Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFFHigh Throughput Dna Sequence AnalyzerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816270020125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816270020125008162700201258162700201250816270020125

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033305264
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816270020415Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx20063024200630242022-11-07
00816270020330DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx200747302026-04-27
00816270020217TruSight™ Oncology Comprehensive 200325732024-12-09
00816270020644TruSight™ Oncology RNA Control200650422024-12-09
00816270020651TruSight™ Oncology DNA Control IVD200650412024-12-09
00816270020088Praxis Extended RAS Panel20012431200124312017-08-28
00816270020262Local Run Manager CF Clinical Sequencing Analysis Module20046734200467342023-06-15
00816270020286Local Run Manager CF 139 Variant Analysis Module20047009200470092023-06-15
00816270020378Local Run Manager CF 139-Variant 2.0 Micro Analysis Module20072975200729752023-06-15
00816270020385Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module20072974200729742023-06-15
00816270020149TruSight™ Cystic Fibrosis Library Preparation20036925200369252020-04-09
00816270020019MiSeqDx CF 139 Variant Assay (2 Run)15036580DX-102-10042016-09-21
00816270020026MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)15036620DX-102-10012016-09-21
00816270020033MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)15036577DX-102-10032017-08-14
00816270020392Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx20063022200630222022-11-07
00816270020743DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx20074609200746092022-11-07
00816270020453Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)20051352200513522022-10-20
00816270020460Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)20051353200513532022-10-20
00816270020477Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples)20051354200513542022-10-20
00816270020484Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)20051355200513552022-10-20

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