DEVICE: NextSeq550Dx Reagent Kit v2(300 cyc) IVD (00816270020095)
Device Identifier (DI) Information
NextSeq550Dx Reagent Kit v2(300 cyc) IVD
20019554
Not in Commercial Distribution
20019554
ILLUMINA, INC.
20019554
Not in Commercial Distribution
20019554
ILLUMINA, INC.
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62173 | 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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PFT | Reagents For Molecular Diagnostic Test Systems |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Storage Environment Temperature: between -25 and -15 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0c162c60-2ff1-4a56-ad37-1f83a3f3e165
September 26, 2022
4
February 09, 2018
September 26, 2022
4
February 09, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined