Medical device licence · 103907 · Class 2
ALINITY C ECSTASY
Yes: licensed in Canada
Licence status Issued (active); first licensed November 20, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103907
- Licence holder
- Microgenics CorporationFremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 20, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY C ECSTASY QUAL CALIBRATOR KIT
- ALINITY C ECSTASY REAGENT KIT
- ALINITY C ECSTASY SEMIQUANT CALIBRATOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.