TruSight™ Oncology DNA Control IVD

Basic Information

• Brand Name: TruSight™ Oncology DNA Control IVD
• Primary DI: 00816270020651
• Version / Model: 20065041
• Company Name: ILLUMINA, INC.
• Labeler DUNS: 033305264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-09
• Public Version: 1
• Public Version Date: 2024-12-17
• Public Version Status: New
• Public Device Record Key: 41bb4506-11fe-47aa-b289-a49f4e662a92

Device Description

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.

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: No
• Has Lot/Batch Number: Yes
• 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
SCU	Dna And Rna Oncology Controls	Microbiology	866.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66133	Cancer-related multiple gene mutation profile IVD, control	A material which is used to verify the performance of an assay intended to be used for genomic profiling/screening of multiple genes associated with cancer to detect specific types of mutations [e.g., single nucleotide variants (SNVs), insertions, deletions, fusions, translocations and/or copy number variations (CNVs)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816270020651	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]