NextSeq550Dx Reagent Kit v2(300 cyc) IVD 20019554

GUDID 00816270020095

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.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 00816270020095
• NIH Device Record Key: 0c162c60-2ff1-4a56-ad37-1f83a3f3e165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextSeq550Dx Reagent Kit v2(300 cyc) IVD
• Version Model Number: 20019554
• Catalog Number: 20019554
• Company DUNS: 033305264
• Company Name: ILLUMINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020095 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-01
• Device Publish Date: 2018-02-09

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