Medical device licence · 80777 · Class 4
ANTI-HCV TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 1, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80777
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 1, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS ANTI-HCV II
- ELECSYS ANTI-HCV II (DONOR SCREENING FOR TRANSPLANTATION)
- ELECSYS PRECICONTROL ANTI-HCV
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.