Medical device licence · 112581 · Class 4
COBAS MALARIA
Yes: licensed in Canada
Licence status Issued (active); first licensed January 23, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112581
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- January 23, 2025
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS MALARIA
- COBAS MALARIA CONTROL KIT
- COBAS NHP NEGATIVE CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.