Medical device licence · 115953 · Class 4
ALINITY S HBSAG
Yes: licensed in Canada
Licence status Issued (active); first licensed August 13, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115953
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- August 13, 2026
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY S HBSAG ASSAY CONTROL KIT
- ALINITY S HBSAG CALIBRATOR KIT
- ALINITY S HBSAG REAGENT KIT
- ALINITY S HBSAG RELEASE CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.