Medical device licence · 105614 · Class 3
COBAS VIVODX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 16, 2020; ended October 21, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 105614
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 16, 2020
- Ended
- October 21, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS VIVODX INSTRUMENT
- COBAS VIVODX SW IC V1.1.0
- COBAS VIVODX SW WA CORE V1.1.0
- COBAS VIVODX SW WA MRSA V1.0.0
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.