FDA Registration
Active
🇺🇸 United States
CliniSys, Inc
Reg #: 2029302
·
FEI: 1000306472
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CliniSys, Inc
- Registration Number
- 2029302
- FEI Number
- 1000306472
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3300 E. Sunrise Dr.
- City
- TUCSON
- State
- AZ
- ZIP
- 85718
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK160005
Owner / Operator
- Firm Name
- CliniSys, Inc
- Operator Number
- 9010587
- Address
- 3300 E. Sunrise Dr.
- City
- Tucson
- State
- AZ
- Postal Code
- 85718
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2001-01-16 |
| Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | NVV | Class 1 | Clinical Chemistry | No | 2007-11-02 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2020-11-03 |
Proprietary Names
Clinisys Atlas®
Clinisys SQ Lab
Clinisys Laboratory Solution (Core)
Clinisys CoPathPlus®
Clinisys VUE Clinical
Clinisys PowerPath®
Clinisys SQ Blood Bank
Establishment Types
Manufacture Medical Device