Medical device licence · 105385 · Class 4
INSTI HIV SELF TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed November 2, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105385
- Licence holder
- Biolytical Laboratories Inc.Richmond, BC, Canada
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- November 2, 2020
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INSTI HIV SELF TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.