Medical device licence · 70504 · Class 3
AXSYM SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed February 20, 2006; ended June 29, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 70504
- Licence holder
- Abbott Ireland Diagnostics DivisionSligo, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 20, 2006
- Ended
- June 29, 2015
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXSYM SYSTEM - CA 125 ASSAY
- AXSYM SYSTEM - CA15-3 ASSAY
- AXSYM SYSTEM - FREE PSA ASSAY
- AXSYM SYSTEM - TOTAL PSA ASSAY
- AXSYM SYSTEM AFP REAGENT ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.