Medical device licence · 11491 · Class 3
ARCHITECT "I" SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11491
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 23, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT "I" SYSTEM - BNP ASSAY
- ARCHITECT "I" SYSTEM - CYCLOSPORINE ASSAY
- ARCHITECT "I" SYSTEM - MPO ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.