DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx 20074609

GUDID 00816270020743

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.

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 00816270020743
• NIH Device Record Key: 3a64e1a9-24f9-4994-b771-ecd5a942975c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx
• Version Model Number: 20074609
• Catalog Number: 20074609
• 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: true
• Serial Number: false
• 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
• Email: techsupport@illumina.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020743 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

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: 2022-11-15
• Device Publish Date: 2022-11-07

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