FDA Registration
Active
🇺🇸 United States
BABSON DIAGNOSTICS
Reg #: 3028019212
·
FEI: 3028019212
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
3
Classifications
4
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Registration Details
- Registration Name
- BABSON DIAGNOSTICS
- Registration Number
- 3028019212
- FEI Number
- 3028019212
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1321 Rutherford Lane, Ste 200
- City
- Austin
- State
- TX
- ZIP
- 78753
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230493
Owner / Operator
- Firm Name
- Babson Diagnostics
- Operator Number
- 10089765
- Address
- 1321 Rutherford Lane, Ste 200
- City
- Austin
- State
- TX
- Postal Code
- 78753
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vacuum Sample, With Anticoagulant | GIM | Class 2 | Clinical Chemistry | No | 2025-11-17 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2024-01-05 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2024-05-02 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-11-17 |
Proprietary Names
BD MiniDraw Capillary Tube Adapter Sysmex XN Only
BD MiniDraw Finger Sizing Tool
Babson Hand Warmer
Babson Sample Preparation Device
BD MiniDraw Capillary Tube Adapter SST
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device