Medical device licence · 116059 · Class 3
ALINITY M BKV
Yes: licensed in Canada
Licence status Issued (active); first licensed August 31, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 116059
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- August 31, 2026
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY M BKV AMP KIT
- ALINITY M BKV CAL KIT
- ALINITY M BKV CTRL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.