Medical device licence · 104122 · Class 2
THE NGAL TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104122
- Licence holder
- Bioporto Diagnostics AHellerup, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 8, 2020
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRONEPHRO AKI (NGAL) CALIBRATOR KIT
- PRONEPHRO AKI (NGAL) CONTROL KIT
- PRONEPHRO AKI (NGAL) REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.