Medical device licence · 100762 · Class 4
ALINITY I HBEAG ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed March 26, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100762
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- March 26, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I HBEAG CALIBRATORS
- ALINITY I HBEAG CONTROLS
- ALINITY I HBEAG QUANTITATIVE CALIBRATORS
- ALINITY I HBEAG QUANTITATIVE CONTROLS
- ALINITY I HBEAG REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.