FDA Registration
Active
🇺🇸 United States
MiSeqDx
Reg #: 3003218906
·
FEI: 3003218906
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
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
- 510(k) Number
- DEN130011
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 |
|---|---|---|---|---|---|
| High Throughput Dna Sequence Analyzer | PFF | Class 2 | Immunology | No | 2014-01-10 |
Proprietary Names
MiSeqDx
MiSeqDx China
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device