Medical device licence · 104089 · Class 3
ALINITY M HCV ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed December 24, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 104089
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 24, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY M HCV AMP KIT
- ALINITY M HCV CAL KIT
- ALINITY M HCV CTRL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.