FDA Registration
Active
🇺🇸 United States
Prosigna(R) Breast Cancer Prognostic Gene Signature Assay
Reg #: 3007808978
·
FEI: 3007808978
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Veracyte, Inc.
- Registration Number
- 3007808978
- FEI Number
- 3007808978
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6000 Shoreline Ct Ste 300
- City
- S San Fran
- State
- CA
- ZIP
- 94080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141771
Owner / Operator
- Firm Name
- Veracyte, Inc.
- Operator Number
- 10035252
- Address
- 6000 Shoreline Court, Suite 300
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
- Correspondent
- Peter Trinder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | NYI | Class 2 | Immunology | No | 2020-01-29 |
Proprietary Names
Prosigna(R) Breast Cancer Prognostic Gene Signature Assay
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198