Medical device licence · 98314 · Class 3
COBAS HBV
Yes: licensed in Canada
Licence status Issued (active); first licensed January 5, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98314
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 5, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS HBV
- COBAS HBV/HCV/HIV-1 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.