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.
00816270020118
GS1

1
033305264 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
PFT Reagents For Molecular Diagnostic Test Systems
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4e415a14-2fa7-4da1-af02-0c49bc9c4895
March 11, 2019
1
February 28, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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