FDA Registration
Active
🇺🇸 United States
467825 Cholesterol Reagent (CHOL 2 x 300)
Reg #: 2050010
·
FEI: 2050010
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050010
- FEI Number
- 2050010
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2470 Faraday Ave
- City
- CARLSBAD
- State
- CA
- ZIP
- 92010
- Country
- US
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2004-07-29 |
Proprietary Names
467825 Cholesterol Reagent (CHOL 2 x 300)
OSR6616 CHOLESTEROL
SYNCHRON Cholesterol
OSR6516 CHOLESTEROL
OSR6216 CHOLESTEROL
OSR6116 CHOLESTEROL
BECKMAN ENZYMATIC CH
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)