Medical device licence · 100942 · Class 3
COBAS HBV
Yes: licensed in Canada
Licence status Issued (active); first licensed May 3, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100942
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 3, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 4800 SYSTEM LYSIS KIT 2
- COBAS 4800 SYSTEM SAMPLE PREPARATION KIT 2
- COBAS 4800 SYSTEM SPECIMEN DILUENT 2
- COBAS HBV
- COBAS HBV/HCV/HIV-1 CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.