Medical device licence · 73506 · Class 4
ARCHITECT "I" SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 8, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73506
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- March 8, 2007
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT "I" SYSTEM - HBSAG ASSAY
- ARCHITECT ANTI-HBS CALIBRATOR
- ARCHITECT ANTI-HBS CONTROLS
- ARCHITECT ANTI-HBS REAGENT KIT
- ARCHITECT ANTI-HBS SPECIMEN DILUENT
- ARCHITECT HBSAG
- ARCHITECT HBSAG CALIBRATORS
- ARCHITECT HBSAG NEXT CONFIRMATORY MANUAL DILUENT
- ARCHITECT HBSAG NEXT CONFIRMATORY REAGENT KIT
- ARCHITECT HBSAG NEXT QUALITATIVE CALIBRATORS
- ARCHITECT HBSAG NEXT QUALITATIVE CONTROLS
- ARCHITECT HBSAG NEXT QUALITATIVE REAGENT KIT
- ARCHITECT HBSAG QUALITATIVE II CALIBRATORS (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REGENT MANUAL DILUENT (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT HBSAG QUALITATIVE II CONTROLS (DONOR SCREENING & CADAVERIC TESTING)
- ARCHITECT HBSAG QUALITATIVE II REAGENT KIT DONOR SCREEN (DONOR SCREENING & CADAVERIC TESTING)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.