Medical device licence · 101358 · Class 2
ARK METHYLPHENIDATE METABOLITE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101358
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 5, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK METHYLPHENIDATE METABOLITE ASSAY
- ARK METHYLPHENIDATE METABOLITE CALIBRATOR
- ARK METHYLPHENIDATE METABOLITE CONTROL
- ARK METHYLPHENIDATE METABOLITE CUTOFF CALIBRATOR
- ARK METHYLPHENIDATE METABOLITE NEGATIVE CALIBRATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.