Medical device licence · 114174 · Class 4
ORAQUICK HIV SELF-TEST
Yes: licensed in Canada
Licence status Issued with conditions; first licensed October 22, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114174
- Licence holder
- Orasure Technologies, Inc.Bethlehem, PA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- October 22, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORAQUICK HIV SELF-TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.