Medical device licence · 100128 · Class 2
ARK ETHYL GLUCURONIDE
Yes: licensed in Canada
Licence status Issued (active); first licensed December 4, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100128
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- December 4, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK ETHYL GLUCURONIDE ASSAY
- ARK ETHYL GLUCURONIDE CALIBRATOR
- ARK ETHYL GLUCURONIDE CONTROL
- ARK ETHYL GLUCURONIDE CUTOFF CALIBRATOR
- ARK ETHYL GLUCURONIDE CUTOFF NEGATIVE CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.