Medical device licence · 115230 · Class 2
ARCHITECT IPHENYTOIN
Yes: licensed in Canada
Licence status Issued (active); first licensed April 17, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115230
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 17, 2026
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT IPHENYTOIN CALIBRATORS
- ARCHITECT IPHENYTOIN REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.