FDA Registration
Active
🇺🇸 United States
UACR
Reg #: 3018739912
·
FEI: 3018739912
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- RENALYTIXAI
- Registration Number
- 3018739912
- FEI Number
- 3018739912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 6th Avenue, 3 Fl. Rm 324
- City
- New York
- State
- NY
- ZIP
- 10013
- Country
- US
Owner / Operator
- Firm Name
- Renalytix
- Operator Number
- 10081544
- Address
- 101 6th Avenue, 3 Fl. Rm 324
- City
- New York
- State
- NY
- Postal Code
- 10013
- Country
- US
- Correspondent
- Anna Flynn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2024-05-01 |
Proprietary Names
UACR
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198