NextSeq550Dx Reagent Kit v2(300 cyc) IVD - The NextSeq™ 550Dx High Output Reagent Kit v2 - ILLUMINA, INC.

Duns Number:033305264

Device Description: The NextSeq™ 550Dx High Output Reagent Kit v2 (300 cycles) is intended for sequencing DNA 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.

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More Product Details

Catalog Number

20019554

Brand Name

NextSeq550Dx Reagent Kit v2(300 cyc) IVD

Version/Model Number

20019554

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PFT

Product Code Name

Reagents For Molecular Diagnostic Test Systems

Device Record Status

Public Device Record Key

0c162c60-2ff1-4a56-ad37-1f83a3f3e165

Public Version Date

September 26, 2022

Public Version Number

4

DI Record Publish Date

February 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ILLUMINA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 7
3 A medical device with high risk that requires premarket approval 1