FDA UDI
In Commercial Distribution
🇺🇸 United States
TruSight™ Oncology Comprehensive
DI: 00816270020217
·
Model: 20032573
·
ILLUMINA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TruSight™ Oncology Comprehensive
- Primary DI
- 00816270020217
- Version / Model
- 20032573
- 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
- 71f021e9-47d4-4594-80f4-5114bfab2d6f
Device Description
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.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60943 | Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816270020217 | GS1 |
Customer Contacts
- Phone
- 800-809-4566
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230011 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius