Medical device licence · 103666 · Class 4
ALINITY M SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 30, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103666
- Licence holder
- Abbott Molecular Inc.Des Plaines, IL, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 30, 2019
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALINITY M DILUENT SOLUTION
- ALINITY M ETHANOL SOLUTION
- ALINITY M LYSIS SOLUTION
- ALINITY M SAMPLE PREP KIT 1
- ALINITY M SAMPLE PREP KIT 2
- ALINITY M SPECIMEN DILUTION KIT I
- ALINITY M SYSTEM
- ALINITY M SYSTEM SOFTWARE
- ALINITY M VAPOR BARRIER SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.