FDA Registration
Active
🇺🇸 United States
DxFLEX Sheath Fluid
Reg #: 1061932
·
FEI: 3000203293
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 1061932
- FEI Number
- 3000203293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11800 SW 147TH AVE.
- City
- Miami
- State
- FL
- ZIP
- 33196
- 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
- Correspondent
- David G Davis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 1977-12-14 |
Proprietary Names
DxFLEX Sheath Fluid
ISOFLOW Sheath Fluid
AQUIOS Sheath Solution
AcT 5diff Diluent
DxH 500 Series Diluent (PN B36845)
DxH Diluent
DxH ECO Diluent
DxH Concentrated ECO Diluent
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility