Medical device licence · 110498 · Class 3
HBV CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 1, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110498
- Licence holder
- Exact DiagnosticsFort Worth, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 1, 2023
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BULK NEGATIVE
- HBV HIGH RUN CONTROL
- HBV LOW RUN CONTROL
- NEGATIVE RUN CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.