Medical device licence · 99366 · Class 2
ALINITY I SYSTEM ASSAYS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99366
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 29, 2017
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY I ANTI-TG CALIBRATORS
- ALINITY I ANTI-TG CONTROLS
- ALINITY I ANTI-TG REAGENT KIT
- ALINITY I ANTI-TPO CALIBRATORS
- ALINITY I ANTI-TPO CONTROLS
- ALINITY I ANTI-TPO REAGENT KIT
- ALINITY I B-R-A-H-M-S PCT CALIBRATORS
- ALINITY I B-R-A-H-M-S PCT CONTROLS
- ALINITY I B-R-A-H-M-S PCT REAGENT KIT
- ALINITY I CORTISOL CALIBRATORS
- ALINITY I CORTISOL REAGENT KIT
- ALINITY I T-UPTAKE CALIBRATORS
- ALINITY I T-UPTAKE CONTROLS
- ALINITY I T-UPTAKE REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.