Medical device licence · 111885 · Class 3
HSV-2 CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 26, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111885
- Licence holder
- Exact DiagnosticsFort Worth, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- September 26, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BULK CSF NEGATIVE CONTROL
- HSV-2 HIGH RUN CONTROL
- HSV-2 LOW RUN CONTROL
- SYNTHETIC NEGATIVE RUN CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.