FDA Registration
Active
🇺🇸 United States
IntelliSep Quality Control Kit
Reg #: 3017448032
·
FEI: 3017448032
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CYTOVALE, INC.
- Registration Number
- 3017448032
- FEI Number
- 3017448032
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Tower Pl Fl 18
- City
- South San Francisco
- State
- CA
- ZIP
- 94080
- Country
- US
Owner / Operator
- Firm Name
- Cytovale, Inc.
- Operator Number
- 10088591
- Address
- 2 Tower Place, 18th Floor
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
- Correspondent
- Sarah Esterquest
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2023-08-23 |
Proprietary Names
IntelliSep Quality Control Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198