TruSight™ Oncology DNA Control IVD

GUDID 00816270020651

The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of Next Generation Sequencing based molecular diagnostic assays used for the detection of select DNA and RNA variants.

ILLUMINA, INC.

Cancer-related multiple gene mutation profile IVD, control

• Primary Device ID: 00816270020651
• NIH Device Record Key: 41bb4506-11fe-47aa-b289-a49f4e662a92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSight™ Oncology DNA Control IVD
• Version Model Number: 20065041
• 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
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020651 [Primary]

FDA Product Code

• SCU: Dna And Rna Oncology Controls

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: 2024-12-17
• Device Publish Date: 2024-12-09

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: 2024-12-17The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of Next Generation Sequencing based molecular diagnostic assays used for the detection of select DNA and RNA variants.
• 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
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• 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