Medical device licence · 102765 · Class 2
ARK PREGABALIN II
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102765
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 18, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK PREGABALIN II ASSAY
- ARK PREGABALIN II CALIBRATOR
- ARK PREGABALIN II CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.