NovaSeq™ 6000Dx 20068232
GUDID 00816270020637
The NovaSeq™ 6000Dx Instrument is intended for sequencing DNA libraries with in vitro diagnostic assays. For its input, the NovaSeq™ 6000Dx 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 Real-Time Analysis (RTA) software performs image analysis and base calling and assigns a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis can be executed on the included and required Illumina DRAGEN Server for NovaSeq™ 6000Dx to process base calls. The NovaSeq™ 6000Dx uses different secondary analysis applications depending on the workflow.
ILLUMINA, INC.
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)| Primary Device ID | 00816270020637 |
| NIH Device Record Key | 373a8444-ff8e-4ca2-94f0-a0b765d227e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaSeq™ 6000Dx |
| Version Model Number | 20068232 |
| Catalog Number | 20068232 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com | |
| Phone | 800-809-4566 |
| techsupport@illumina.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Humidity | Between 20 Degrees Celsius and 80 Degrees Celsius |
| Handling Environment Temperature | Between 19 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816270020637 [Primary] |
FDA Product Code
| PFF | High Throughput Dna Sequence Analyzer |
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 | 2022-10-26 |
| Device Publish Date | 2022-10-18 |
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 |
Trademark Results [NovaSeq]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVASEQ 87474750 not registered Live/Pending |
Illumina Inc. 2017-06-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.