Medical device licence · 84461 · Class 4
ARCHITECT SYSTEMS REAGENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 17, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84461
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 17, 2010
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT ARM CONCENTRATED WASH BUFFER
- ARCHITECT CONCENTRATED WASH BUFFER
- ARCHITECT MULTI-ASSAY DILUENT
- ARCHITECT PRE-TRIGGER SOLUTION
- ARCHITECT PROBE CONDITIONING SOLUTION
- ARCHITECT TRIGGER SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.