ApprovalTrail

Medical device licence · 112880 · Class 2

ARCHITECT LIPASE2

Yes: licensed in Canada

Licence status Issued (active); first licensed March 17, 2025. It is in Health Canada’s list of active licences.
Licence number
112880
Licence holder
Abbott Ireland Diagnostics DivisionSligo, Ireland
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
March 17, 2025
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ARCHITECT LIPASE2
  • ARCHITECT LIPASE2 CALIBRATOR

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.