FDA Registration
Active
🇺🇸 United States
TruSight Oncology Comprehensive
Reg #: 3003218906
·
FEI: 3003218906
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Illumina, Inc.
- Registration Number
- 3003218906
- FEI Number
- 3003218906
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5200 Illumina Way
- City
- San Diego
- State
- CA
- ZIP
- 92122
- Country
- US
Regulatory Submissions
- PMA Number
- P230011
Owner / Operator
- Firm Name
- Illumina, Inc.
- Operator Number
- 10030352
- Address
- 5200 Illumina Way
- City
- San Diego
- State
- CA
- Postal Code
- 92122
- Country
- US
- Correspondent
- Karen Gutekunst
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | Class 3 | Unknown | No | 2024-08-26 |
Proprietary Names
TruSight Oncology Comprehensive
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device