Medical device licence · 71693 · Class 3
ARCHITECT I SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71693
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 23, 2006
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT CYCLOSPORINE CALIBRATORS
- ARCHITECT CYCLOSPORINE REAGENT KIT
- ARCHITECT I SYSTEM - AFP ASSAY
- ARCHITECT I SYSTEM - CMV IGG ASSAY
- ARCHITECT I SYSTEM - CMV IGG AVIDITY ASSAY
- ARCHITECT I SYSTEM - CMV IGM ASSAY
- ARCHITECT I SYSTEM - FREE PSA ASSAY
- ARCHITECT I SYSTEM - RUBELLA IGM REAGENT ASSAY
- ARCHITECT I SYSTEM - TOTAL PSA ASSAY
- ARCHITECT RUBELLA IGG CALIBRATORS
- ARCHITECT RUBELLA IGG CONTROLS
- ARCHITECT RUBELLA IGG REAGENT KIT
- ARCHITECT RUBELLA IGM CONTROLS
- ARCHITECT SIROLIMUS CALIBRATORS
- ARCHITECT SIROLIMUS REAGENT KIT
- ARCHITECT SIROLIMUS WHOLE BLOOD PRECIPITATION REAGENT
- ARCHITECT STAT CK-MB CALIBRATORS
- ARCHITECT STAT CK-MB CONTROLS
- ARCHITECT STAT CK-MB REAGENT KIT
- ARCHITECT STAT MYOGLOBIN CALIBRATORS
- ARCHITECT STAT MYOGLOBIN CONTROLS
- ARCHITECT STAT MYOGLOBIN REAGENT KIT
- ARCHITECT TACROLIMUS CALIBRATORS
- ARCHITECT TACROLIMUS REAGENT KIT
- ARCHITECT TACROLIMUS WHOLE BLOOD PRECIPITATION REAGENT
- ARCHITECTI SYSTEM - CEA ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.