Medical device licence · 113241 · Class 3
I-STAT TBI TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed May 6, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113241
- Licence holder
- Abbott Point Of Care Inc.Abbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 6, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- I-STAT TBI CALIBRATION VERIFICATION LEVELS 1-3
- I-STAT TBI CARTRIDGE
- I-STAT TBI CONTROL LEVEL 1
- I-STAT TBI CONTROL LEVEL 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.