Medical device licence · 101917 · Class 2
ARK EDDP
Yes: licensed in Canada
Licence status Issued (active); first licensed October 22, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101917
- Licence holder
- Ark Diagnostics, Inc.Fremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 22, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARK EDDP 100 NG/ML CUTOFF CALIBRATOR
- ARK EDDP 300 NG/ML CUTOFF CALIBRATOR
- ARK EDDP ASSAY
- ARK EDDP CALIBRATOR
- ARK EDDP CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.