AccessGUDID - DEVICE: NovaSeq™ 6000Dx (00816270020637)

GUDID

Device Identifier (DI) Information

Brand Name: NovaSeq™ 6000Dx
Version or Model: 20068232
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20068232
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFF	High Throughput Dna Sequence Analyzer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 80 Degrees Celsius
Handling Environment Temperature: between 19 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 373a8444-ff8e-4ca2-94f0-a0b765d227e9
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022