Medical device licence · 86860 · Class 3
RAPID RESPONSE 1-STEP DOA TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed August 8, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86860
- Licence holder
- Btnx Inc.Pickering, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- August 8, 2011
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAPID RESPONSE 1-STEP DOA CUP
- RAPID RESPONSE 1-STEP DOA PANEL
- RAPID RESPONSE 1-STEP DOA TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.