Medical device licence · 71552 · Class 2
ARCHITECT I SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 7, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71552
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 7, 2006
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT 'I' SYSTEM B12 ASSAY
- ARCHITECT 25-OH VITAMIN D CALIBRATORS
- ARCHITECT 25-OH VITAMIN D CONTROLS
- ARCHITECT 25-OH VITAMIN D REAGENT
- ARCHITECT FREE T3
- ARCHITECT FREE T4 CALIBRATORS
- ARCHITECT FREE T4 REAGENT KIT
- ARCHITECT I SYSTEM - ESTRADIOL ASSAY
- ARCHITECT I SYSTEM - FERRITIN ASSAY
- ARCHITECT I SYSTEM - FOLATE ASSAY
- ARCHITECT I SYSTEM - FREE T3 ASSAY
- ARCHITECT I SYSTEM - FREE T4 ASSAY
- ARCHITECT I SYSTEM - FSH ASSAY
- ARCHITECT I SYSTEM - PROGESTERONE ASSAY
- ARCHITECT I SYSTEM - PROLACTIN ASSAY
- ARCHITECT I SYSTEM - TOTAL BETA-HCG ASSAY
- ARCHITECT I SYSTEM - TOTAL T3 ASSAY
- ARCHITECT I SYSTEM - TSH ASSAY
- ARCHITECT I SYSTEM - URINE NGAL REAGENT
- ARCHITECT LH CALIBRATORS
- ARCHITECT LH REAGENT KIT
- ARCHITECT TOTAL T3
- ARCHITECT TOTAL T4 ASSAY
- ARCHITECT TOTAL T4 CALIBRATORS
- ARCHITECT TOTAL T4 CONTROLS
- ARCHITECT TOTAL T4 REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.