FDA Registration
Active
🇺🇸 United States
DAXOR CORPORATION
Reg #: 3003529145
·
FEI: 3003857949
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- DAXOR CORPORATION
- Registration Number
- 3003529145
- FEI Number
- 3003857949
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 107 Meco Ln
- City
- Oak Ridge
- State
- TN
- ZIP
- 37830
- Country
- US
Regulatory Submissions
- 510(k) Number
- K964406
Owner / Operator
- Firm Name
- DAXOR CORPORATION
- Operator Number
- 2434654
- Address
- 107 Meco Lane, --
- City
- Oak Ridge
- State
- TN
- Postal Code
- 37830
- Country
- US
- Correspondent
- Linda - Cooper
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Counter (Beta, Gamma) For Clinical Use | JJJ | Class 1 | Clinical Chemistry | No | 2004-02-18 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2006-06-01 |
| Device, Blood Volume Measuring | JWO | Class 2 | Hematology | No | 2004-02-18 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2006-06-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2004-02-18 |
Proprietary Names
Gamma Counter (DGX1)
Sample Changer (SC-25)
BVA-100 BVA Software
BVA-100 Convenience Kit
Daxor BVA
Max-100 Syringe
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198