Medical device licence · 91455 · Class 2
TG II ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed June 6, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91455
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 6, 2013
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS TG II
- PRECICONTROL THYRO SENSITIVE
- TG II CALSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.