Medical device licence · 105846 · Class 2
ALINITY I THYROGLOBULIN ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed February 11, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105846
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 11, 2021
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I THYROGLOBULIN CALIBRATORS
- ALINITY I THYROGLOBULIN CONTROLS
- ALINITY I THYROGLOBULIN REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.