FDA Registration
Active
🇺🇸 United States
446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2050012
- FEI Number
- 2050012
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 250 S Kraemer Blvd
- City
- BREA
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K963868
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 |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2013-02-01 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2013-02-01 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2013-02-01 |
Proprietary Names
446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
446460 IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
447610 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility