FDA Registration
Active
🇺🇸 United States
AXP AutoXpress Platform; AXP System
Reg #: 2950374
·
FEI: 1000123765
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ThermoGenesis Corp.
- Registration Number
- 2950374
- FEI Number
- 1000123765
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2890 Kilgore Rd
- City
- RANCHO CORDOVA
- State
- CA
- ZIP
- 95670
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK070006
Owner / Operator
- Firm Name
- Thermogenesis Corp.
- Operator Number
- 9023456
- Address
- 2890 Kilgore Road, --
- City
- Rancho Cordova
- State
- CA
- Postal Code
- 95670
- Country
- US
- Correspondent
- Jason - Le
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cord Blood Processing System And Storage Container | OAO | Class 2 | Hematology | No | 2007-12-10 |
Proprietary Names
AXP AutoXpress Platform; AXP System
AXP Medium Oval Bucket Adapter Set
AXP Large Oval Bucket Adapter Set
Component Retaining Clip Set, AXP
AXP Adapter Set, Sorvall 11754/11297
AXP Sorvall 11754 Bucket Pads, Package Of 2
AXP Device
Counterweight, AXP
Freezing Bag Set
AXP Adapter, 101-102 mm Round Bucket
AXP Docking Station
Start Up Accessory Kit, AXP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device