FDA Registration
Active
🇨🇦 Canada
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Reg #: 3005643513
·
FEI: 3005643513
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- ABBOTT POINT OF CARE CANADA LIMITED
- Registration Number
- 3005643513
- FEI Number
- 3005643513
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 185 CORKSTOWN ROAD
- City
- Ottawa Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K210958
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- Abbott Point of Care
- Contact Name
- Jose Colon
- Address
- 400 College Road East
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
- [email protected]
- Phone
- 609 4549356
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2021-08-25 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2021-08-25 |
Proprietary Names
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Establishment Types
Manufacture Medical Device