Medical device licence · 112016 · Class 4
RESPIRATORY CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 18, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112016
- Licence holder
- Exact DiagnosticsFort Worth, TX, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- October 18, 2024
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RESPIRATORY NEGATIVE RUN CONTROL
- RESPIRATORY POSITIVE RUN CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.