Medical device licence · 109009 · Class 2
DIGITAL LIGHTCYCLER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 2, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109009
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 2, 2023
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIGITAL LIGHTCYCLER 5X DNA MASTER
- DIGITAL LIGHTCYCLER 5X RNA MASTER
- DIGITAL LIGHTCYCLER ANALYZER
- DIGITAL LIGHTCYCLER DEVELOPMENT SOFTWARE
- DIGITAL LIGHTCYCLER PARTITIONING ENGINE
- DIGITAL LIGHTCYCLER PARTITIONING FLUID
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.