Medical device licence · 96109 · Class 2
GEN 2 HEMOLYZING REAGENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96109
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 18, 2015
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- A1CD HEMOLYZING REAGENT
- A1CD2 HEMOLYZING REAGENT GEN 2
- HEMOLYZING REAGENT GEN 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.