FDA Registration
Active
🇺🇸 United States
Sepsis ImmunoScore
Reg #: 3014456004
·
FEI: 3014456004
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRENOSIS, INC.
- Registration Number
- 3014456004
- FEI Number
- 3014456004
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3440 S Dearborn St, Suite 216S
- City
- Chicago
- State
- IL
- ZIP
- 60616
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN230036
Owner / Operator
- Firm Name
- Prenosis, Inc.
- Operator Number
- 10091847
- Address
- 3440 S Dearborn St, Suite 216S
- City
- Chicago
- State
- IL
- Postal Code
- 60616
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Software Device To Aid In The Prediction Or Diagnosis Of Sepsis | SAK | Class 2 | General Hospital | No | 2024-11-07 |
Proprietary Names
Sepsis ImmunoScore
Establishment Types
Manufacture Medical Device