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
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP

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