FDA Registration
Active
🇺🇸 United States
oncoReveal CDx Box 1
Reg #: 3020703032
·
FEI: 3016560486
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PILLAR BIOSCIENCES
- Registration Number
- 3020703032
- FEI Number
- 3016560486
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Strathmore Road
- City
- Natick
- State
- MA
- ZIP
- 01760
- Country
- US
Regulatory Submissions
- PMA Number
- P200011
Owner / Operator
- Firm Name
- Pillar Biosciences
- Operator Number
- 10082584
- Address
- 9 Strathmore Road
- City
- Natick
- State
- MA
- Postal Code
- 01760
- Country
- US
- Correspondent
- Sean W Snyder
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 | 2021-08-19 |
Proprietary Names
oncoReveal CDx Box 1
PiVAT Software
oncoReveal CDx Box 3
oncoReveal CDx Box 4
oncoReveal CDx Box 2
oncoReveal CDx
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198