Identity
- Trade Name
- TruSight™ Oncology DNA Control IVD FDA UDI
- Generic Name
- Cancer-related multiple gene mutation profile IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 20065041 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816270020651 FDA UDI
- FDA Product Code
- SCU FDA UDI
- GMDN Term
- Cancer-related multiple gene mutation profile IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cancer-related multiple gene mutation profile IVD, control
TruSight™ Oncology DNA Control IVD by Illumina, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cancer-related multiple gene mutation profile IVD, control.
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- Mimix™ Quantitative Multiplex FFPE reference standard — REVVITY DISCOVERY LIMITED · Class I
- TruSight™ Oncology RNA Control — Illumina, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Illumina, Inc.
Sources (1)
- FDA UDI 41bb4506-11fe-47aa-b289-a49f4e662a92 34 fields · synced Jun 8, 2026