Medical device licence · 111747 · Class 2
ARK HYDROCODONE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 27, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111747
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 27, 2024
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK HYDROCODONE ASSAY
- ARK HYDROCODONE CALIBRATOR
- ARK HYDROCODONE CONTROL
- ARK HYDROCODONE CUTOFF CALIBRATOR
- ARK HYDROCODONE NEGATIVE CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.