FDA Registration
Active
🇺🇸 United States
23andMe BRCA1/BRCA2 (Selected Variants) Report
Reg #: 3007699459
·
FEI: 3007699459
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 23ANDME, INC.
- Registration Number
- 3007699459
- FEI Number
- 3007699459
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 223 N Mathilda Ave
- City
- Sunnyvale
- State
- CA
- ZIP
- 94086
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223597
Owner / Operator
- Firm Name
- 23andMe, Inc.
- Operator Number
- 10029404
- Address
- 223 N. Mathilda Ave.
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Mark Pisaro
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cancer Predisposition Risk Assessment System | QAZ | Class 2 | Medical Genetics | No | 2023-11-27 |
Proprietary Names
23andMe BRCA1/BRCA2 (Selected Variants) Report
Establishment Types
Manufacture Medical Device