Medical device licence · 84429 · Class 2
ARK GABAPENTIN ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed November 15, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84429
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 15, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK GABAPENTIN ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.