Medical device licence · 99170 · Class 2
ARK FENTANYL
Yes: licensed in Canada
Licence status Issued (active); first licensed May 16, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99170
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 16, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK FENTANYL ASSAY
- ARK FENTANYL CALIBRATOR
- ARK FENTANYL CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.