Medical device licence · 104175 · Class 3
ALINITY M STI
Yes: licensed in Canada
Licence status Issued (active); first licensed January 23, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104175
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- January 23, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY M STI AMP KIT
- ALINITY M STI CTRL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.