Medical device licence · 103311 · Class 2
ARK AB-PINACA
Yes: licensed in Canada
Licence status Issued (active); first licensed July 22, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103311
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 22, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK AB-PINACA ASSAY
- ARK AB-PINACA CONTROL
- ARK AB-PINACA CUTOFF CALIBRATOR
- ARK AB-PINACA NEGATIVE CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.