DEVICE: NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) (00816270020118)
Device Identifier (DI) Information
NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)
20028871
In Commercial Distribution
20028871
ILLUMINA, INC.
20028871
In Commercial Distribution
20028871
ILLUMINA, INC.
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is a single-use set of reagents and consumables for sequencing on the NextSeq™ 550Dx instrument. For its input, the NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) uses libraries generated from DNA where sample indexes and capture sequences are added
to amplified 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 fluorescently-labeled single nucleotide bases as they are incorporated into growing DNA strands.
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier:
20019555, NextSeq™ 550Dx High Output Reagent Cartridge v2, 300 cycles;
20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles;
20026365, NextSeq™ 550Dx High Output Flow Cell Cartridge v2.5, 300 cycles;
20019558, NextSeq™ 550Dx Accessory Box – 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
4e415a14-2fa7-4da1-af02-0c49bc9c4895
March 11, 2019
1
February 28, 2019
March 11, 2019
1
February 28, 2019
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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No Package DIs found |
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