NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) 20028870

GUDID 00816270020132

The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 00816270020132
• NIH Device Record Key: cd57fb4b-787d-479b-924c-e48450391f47
• Commercial Distribution Discontinuation: 2019-04-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
• Version Model Number: 20028870
• Catalog Number: 20028870
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020132 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-04-15

Devices Manufactured by ILLUMINA, INC.

• 00816270020217 - TruSight™ Oncology Comprehensive: 2024-12-17 The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic t
• 00816270020644 - TruSight™ Oncology RNA Control: 2024-12-17 The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality
• 00816270020651 - TruSight™ Oncology DNA Control IVD: 2024-12-17 The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality
• 00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module: 2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin
• 00816270020286 - Local Run Manager CF 139 Variant Analysis Module: 2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass
• 00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module: 2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p
• 00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module: 2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass
• 00816270020392 - Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx: 2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri