Medical device licence · 102246 · Class 2
START (ANTIGEN EXPRESS REAGENT)
Yes: licensed in Canada
Licence status Issued (active); first licensed January 10, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102246
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- January 10, 2019
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- START ANTIGEN EXCESS REAGENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.