FDA Registration
Active
🇺🇸 United States
UniCel DxI 800 Access Immunoassay System (P/N: 973100)
Reg #: 2122870
·
FEI: 2122870
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2122870
- FEI Number
- 2122870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1000 LAKE HAZELTINE DR.
- City
- CHASKA
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K023764
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 |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2014-03-14 |
Proprietary Names
UniCel DxI 800 Access Immunoassay System (P/N: 973100)
Establishment Types
Manufacture Medical Device