NovaSeq™ 6000Dx S2 Buffer Cartridge 20062292

GUDID 00816270020545

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.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD
Primary Device ID00816270020545
NIH Device Record Key75be1209-4e68-4142-ac94-514f76ca19a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaSeq™ 6000Dx S2 Buffer Cartridge
Version Model Number20062292
Catalog Number20062292
Company DUNS033305264
Company NameILLUMINA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020545 [Primary]

FDA Product Code

PFTReagents For Molecular Diagnostic Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-26
Device Publish Date2022-10-18

Devices Manufactured by ILLUMINA, INC.

00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module2023-07-13 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 Module2023-07-13 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 Module2023-07-13 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 Module2023-07-13 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™Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri
00816270020415 - Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, a
00816270020743 - DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx2022-11-15 The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, ru
00816270020453 - Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)2022-10-28 The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from periph

Trademark Results [NovaSeq]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVASEQ
NOVASEQ
87474750 not registered Live/Pending
Illumina Inc.
2017-06-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.