DEVICE: NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) (00816270020569)
Device Identifier (DI) Information
NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)
20046933
In Commercial Distribution
20046933
ILLUMINA, INC.
20046933
In Commercial Distribution
20046933
ILLUMINA, INC.
The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq 6000Dx Instrument. The NovaSeq™ 6000Dx S4 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 S4 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:
20046938, NovaSeq™ 6000Dx S4 Cluster Cartridge; 20046940, NovaSeq™ 6000Dx S4 SBS Cartridge; and 20045448, NovaSeq™ 6000Dx S4 Flow Cell.
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
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FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Temperature: between -25 and -15 Degrees Celsius |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
196581f4-2826-4d35-b521-27024003f9fb
October 26, 2022
1
October 18, 2022
October 26, 2022
1
October 18, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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