Medical device licence · 77540 · Class 3
ARCHITECT I SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77540
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 7, 2008
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT BNP CALIBRATORS
- ARCHITECT BNP CONTROLS
- ARCHITECT BNP REAGENT KIT
- ARCHITECT CA 125 II CALIBRATORS
- ARCHITECT CA 125 II CONTROLS
- ARCHITECT CA 125 II REAGENT KIT (100T)
- ARCHITECT CA 125 II REAGENT KIT (400T)
- ARCHITECT CA 125 II REAGENT KIT (500T)
- ARCHITECT CA 15-3 CALIBRATORS
- ARCHITECT CA 15-3 CONTROLS
- ARCHITECT CA 15-3 REAGENT KIT
- ARCHITECT CA 19-9XR
- ARCHITECT I SYSTEM - EBV EBNA-1 IGG CALIBRATOR
- ARCHITECT I SYSTEM - EBV EBNA-1 IGG CONTROLS
- ARCHITECT I SYSTEM - EBV EBNA-1 IGG REAGENT KIT
- ARCHITECT I SYSTEM - EBV VCA IGG CALIBRATOR
- ARCHITECT I SYSTEM - EBV VCA IGG CONTROLS
- ARCHITECT I SYSTEM - EBV VCA IGG REAGENT KIT
- ARCHITECT I SYSTEM - EBV VCA IGM CALIBRATOR
- ARCHITECT I SYSTEM - EBV VCA IGM CONTROLS
- ARCHITECT I SYSTEM - EBV VCA IGM REAGENT KIT
- ARCHITECT I SYSTEM - GALECTIN-3 REAGENT KIT
- ARCHITECT I SYSTEM - HE4 REAGENT KIT (EPITHELIAL OVARIAN TUMOR ASSOC. AG)
- ARCHITECT I SYSTEM - TOXO IGG AVIDITY REAGENT KIT
- ARCHITECT I SYSTEM - TOXO IGG REAGENT KIT
- ARCHITECT I SYSTEM - TOXO IGM KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.