Home GUDID 00816270020538
NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)
Primary DI 00816270020538
Brand NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)
Company ILLUMINA, INC.
Model 20046931
Catalog number 20046931
Device description 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.
Published 2022-10-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name PFT Reagents For Molecular Diagnostic Test Systems
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PFT Reagents For Molecular Diagnostic Test Systems Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816270020538 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816270020538 00816270020538 816270020538 0816270020538
GMDN Terms# Term, Definition table Term Definition Nucleic acid sequencing reagent kit IVD A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature -25 Degrees Celsius -15 Degrees Celsius Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 033305264 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816270020415 Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx 20063024 20063024 2022-11-07 00816270020330 DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx 20074730 2026-04-27 00816270020217 TruSight™ Oncology Comprehensive 20032573 2024-12-09 00816270020644 TruSight™ Oncology RNA Control 20065042 2024-12-09 00816270020651 TruSight™ Oncology DNA Control IVD 20065041 2024-12-09 00816270020088 Praxis Extended RAS Panel 20012431 20012431 2017-08-28 00816270020262 Local Run Manager CF Clinical Sequencing Analysis Module 20046734 20046734 2023-06-15 00816270020286 Local Run Manager CF 139 Variant Analysis Module 20047009 20047009 2023-06-15 00816270020378 Local Run Manager CF 139-Variant 2.0 Micro Analysis Module 20072975 20072975 2023-06-15 00816270020385 Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module 20072974 20072974 2023-06-15 00816270020149 TruSight™ Cystic Fibrosis Library Preparation 20036925 20036925 2020-04-09 00816270020019 MiSeqDx CF 139 Variant Assay (2 Run) 15036580 DX-102-1004 2016-09-21 00816270020026 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) 15036620 DX-102-1001 2016-09-21 00816270020033 MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) 15036577 DX-102-1003 2017-08-14 00816270020392 Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx 20063022 20063022 2022-11-07 00816270020743 DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx 20074609 20074609 2022-11-07 00816270020453 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples) 20051352 20051352 2022-10-20 00816270020460 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples) 20051353 20051353 2022-10-20 00816270020477 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples) 20051354 20051354 2022-10-20 00816270020484 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples) 20051355 20051355 2022-10-20
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