FDA Registration
Active
🇺🇸 United States
LeukoStrat CDx FLT3 Mutation Assay
Reg #: 3014173060
·
FEI: 3014173060
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Invivoscribe, Inc.
- Registration Number
- 3014173060
- FEI Number
- 3014173060
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10222 Barnes Canyon Road, Building 1
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- PMA Number
- P160040
Owner / Operator
- Firm Name
- Invivoscribe, Inc.
- Operator Number
- 10023809
- Address
- 10222 Barnes Canyon Rd., Bldg 1
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Somatic Gene Mutation Detection System | OWD | Class 3 | Unknown | No | 2017-11-17 |
Proprietary Names
LeukoStrat CDx FLT3 Mutation Assay
Establishment Types
Manufacture Medical Device