Medical device licence · 90198 · Class 2
DRI FENTANYL ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed November 28, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90198
- Licence holder
- Microgenics CorporationFremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 28, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRI FENTANYL ASSAY
- DRI FENTANYL CALIBRATOR
- DRI FENTANYL CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.