Medical device licence · 110403 · Class 2
BKV CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110403
- Licence holder
- Exact DiagnosticsFort Worth, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 15, 2023
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BKV 1E3 IU/ML PRECISION
- BKV 5E5 IU/ML PRECISION
- BKV HIGH RUN CONTROL
- BKV LOD
- BKV LOW RUN CONTROL
- BKV URINE LOD
- BKV VERIFICATION PANEL
- BKV VERIFICATION PANEL 1.4ML
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.