Medical device licence · 99632 · Class 2
ARK LACOSAMIDE ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed September 12, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99632
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 12, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK LACOSAMIDE ASSAY
- ARK LACOSAMIDE CALIBRATOR
- ARK LACOSAMIDE CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.