Medical device licence · 109301 · Class 3
RAPID RESPONSE STREP A RAPID TEST DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 3, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109301
- Licence holder
- Btnx Inc.Pickering, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 3, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAPID RESPONSE STREP A RAPID TEST DEVICE
- STREP A NEGATIVE CONTROL
- STREP A POSITIVE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.