FDA Registration
Active
🇫🇷 France
ORTHO Bovine Albumin Solution Polymerized
Reg #: 3000308930
·
FEI: 3000308930
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ortho-Clinical Diagnostics European Support Center
- Registration Number
- 3000308930
- FEI Number
- 3000308930
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1500 Boulevard Sebastien Brant, B.P. 30335
- City
- Illkirch, CEDEX Bas-Rhin
- Country
- FR
Owner / Operator
- Firm Name
- QuidelOrtho Corp.
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Ortho-Clinical Diagnostics, Inc.
- Contact Name
- Marlene Hanna
- Address
- 100 Indigo Creek Drive
- City
- Rochester
- State
- NY
- ZIP
- 14626
- Country
- US
- [email protected]
- Phone
- 585 4534041
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2022-12-09 |
Proprietary Names
ORTHO Bovine Albumin Solution Polymerized
ORTHO Bovine Serum Albumin, 22% Protein Concentration
Establishment Types
Complaint File Establishment per 21 CFR 820.198