Medical device licence · 13835 · Class 3
X SYSTEMS
No longer licensed: cancelled
Licence status Cancelled; first licensed November 2, 1999; ended November 19, 2013. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 13835
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 2, 1999
- Ended
- November 19, 2013
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- X SYSTEM FLX AUTOMATED ANALYZER - CLASS 3
- X SYSTEM TDX ANALYZER - CLASS 3
- X SYSTEMS CYCLOSPORINE MONOCLONAL WHOLE BLOOD ASSAY
- X SYSTEMS FETAL LUNG MATURITY ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.