NovaSeq™ 6000Dx
Basic Information
- Brand Name
- NovaSeq™ 6000Dx
- Primary DI
- 00816270020637
- Version / Model
- 20068232
- Catalog Number
- 20068232
- 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
- 373a8444-ff8e-4ca2-94f0-a0b765d227e9
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFF | High Throughput Dna Sequence Analyzer | Immunology | 862.2265 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61957 | Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) | A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816270020637 | GS1 |
Customer Contacts
- Phone
- 800-809-4566
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 19 – 25 Degrees Celsius