AccessGUDID - DEVICE: DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx (00816270020743)

GUDID

Device Identifier (DI) Information

Brand Name: DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx
Version or Model: 20074609
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20074609
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, run monitoring, primary and secondary analysis on the NovaSeq™ 6000Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The software (SW) includes the UDI information in the User Interface.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents For Molecular Diagnostic Test Systems

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3a64e1a9-24f9-4994-b771-ecd5a942975c
Public Version Date: November 15, 2022
Public Version Number: 1
DI Record Publish Date: November 07, 2022