Medical device licence · 85391 · Class 2
THE NGAL TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed March 3, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85391
- Licence holder
- Bioporto Diagnostics AHellerup, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 3, 2011
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- THE NGAL TEST CALIBRATOR KIT
- THE NGAL TEST CONTROL KIT
- THE NGAL TEST REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.