FDA Registration
Active
🇺🇸 United States
Creatine Kinase
Reg #: 2939693
·
FEI: 2939693
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ABAXIS, INC.
- Registration Number
- 2939693
- FEI Number
- 2939693
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3240 WHIPPLE RD.
- City
- UNION CITY
- State
- CA
- ZIP
- 94587
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992140
Owner / Operator
- Firm Name
- ZOETIS, INC.
- Operator Number
- 9000378
- Address
- 3240 WHIPPLE RD., --
- City
- Union City
- State
- CA
- Postal Code
- 94587
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2012-03-29 |
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 2012-03-29 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2012-03-29 |
Proprietary Names
Creatine Kinase
Enzymatic Potassium
Total Carbon Dioxide
Establishment Types
Manufacture Medical Device