NovaSeq™ 6000Dx S2 Buffer Cartridge

Basic Information

• Brand Name: NovaSeq™ 6000Dx S2 Buffer Cartridge
• Primary DI: 00816270020545
• Version / Model: 20062292
• Catalog Number: 20062292
• Company Name: ILLUMINA, INC.
• Labeler DUNS: 033305264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-18
• Public Version: 1
• Public Version Date: 2022-10-26
• Public Version Status: New
• Public Device Record Key: 75be1209-4e68-4142-ac94-514f76ca19a5

Device Description

The NovaSeq™ 6000Dx S2 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the Cartridge. The set is boxed together in one box 20046945, NovaSeq™ 6000Dx S2 Buffer Cartridge, which is labeled with the same Device Identifier.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFT	Reagents For Molecular Diagnostic Test Systems	Clinical Chemistry	862.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816270020545	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius