Medical device licence · 101345 · Class 3
ALINITY I BNP ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed July 6, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101345
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- July 6, 2018
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I BNP CALIBRATORS
- ALINITY I BNP CONTROLS
- ALINITY I BNP REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.