Medical device licence · 111740 · Class 2
ARK METHOTREXATE II
Yes: licensed in Canada
Licence status Issued (active); first licensed August 26, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111740
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 26, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK METHOTREXATE II ASSAY
- ARK METHOTREXATE II CALIBRATOR
- ARK METHOTREXATE II CONTROL
- ARK METHOTREXATE II DILUTION BUFFER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.