Medical device licence · 100349 · Class 3
ALINITY I CEA ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed January 5, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100349
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- January 5, 2018
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I CEA CALIBRATORS
- ALINITY I CEA CONTROLS
- ALINITY I CEA REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.