Medical device licence · 109829 · Class 3
HPV CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109829
- Licence holder
- Exact DiagnosticsFort Worth, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- July 31, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EDX HPV GENOTYPE 16 CONTROL
- EDX HPV GENOTYPE 18 CONTROL
- EDX HPV GENOTYPE 68 CONTROL
- EDX HPV NEGATIVE CONTROL
- EDX HPV VERIFICATION PANEL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.