FDA Registration
Active
🇺🇸 United States
469126 Theophylline Reagent (THE 2 x 100)
Reg #: 2050012
·
FEI: 2050012
·
Expires 2025
Products
8
Proprietary Names
7
Establishment Types
1
Classifications
8
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
- K955644
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 |
|---|---|---|---|---|---|
| Nephelometric Inhibition Immunoassay, Phenobarbital | LFN | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Fluorescent Immunoassay Gentamicin | LCQ | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Fluorescent Immunoassay, Tobramycin | LCR | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2009-12-22 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2009-12-22 |
Proprietary Names
469126 Theophylline Reagent (THE 2 x 100)
469137 Gentamicin Reagent (GEN 2 x 100)
469188 Phenytoin Reagent (PHY 2 x 100)
467983 Tobramycin Reagent (TOB 2 x 100)
469112 Carbamazepine Reagent (CAR 2 x 100)
469785 Phenobarbital Reagent (PHE 2 x 100)
469600 SYNCHRON Systems Drug Calibrator 1
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility