Medical device licence · 101766 · Class 2
ARK TRAMADOL
Yes: licensed in Canada
Licence status Issued (active); first licensed September 20, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101766
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 20, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK TRAMADOL ASSAY
- ARK TRAMADOL CALIBRATOR
- ARK TRAMADOL CONTROL
- ARK TRAMADOL CUTOFF
- ARK TRAMADOL NEGATIVE CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.