Medical device licence · 103890 · Class 2
ALINITY C DOA MC CALIBRATORS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103890
- Licence holder
- Microgenics CorporationFremont, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 19, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY C DOA MC NEGATIVE CALIBRATOR KIT
- ALINITY C DOA MC QUAL CALIBRATOR 2 KIT
- ALINITY C DOA MC QUAL LOW CALIBRATOR 1 KIT
- ALINITY C DOA MC SEMIQUANT CALIBRATOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.