TruSight™ Oncology Comprehensive

GUDID 00816270020217

The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.

ILLUMINA, INC.

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00816270020217
• NIH Device Record Key: 71f021e9-47d4-4594-80f4-5114bfab2d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSight™ Oncology Comprehensive
• Version Model Number: 20032573
• Company DUNS: 033305264
• Company Name: ILLUMINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230011

FDA Product Code

• PQP: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

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: 2024-12-17The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
• 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: 2024-12-17 The TruSight Oncology DNA Control and TruSight Oncology RNA Control are control materials sold separately for use as a quality
• 00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module: 2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin
• 00816270020286 - Local Run Manager CF 139 Variant Analysis Module: 2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass
• 00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module: 2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p
• 00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module: 2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass
• 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