Medical device licence · 112026 · Class 3
SIMPLEXA CONGENITAL CMV
Yes: licensed in Canada
Licence status Issued (active); first licensed October 21, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112026
- Licence holder
- Diasorin Molecular LlcCypress, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- October 21, 2024
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIMPLEXA CONGENITAL CMV DIRECT
- SIMPLEXA CONGENITAL CMV DIRECT POSITIVE CONTROL
- SIMPLEXA CONGENITAL CMV DIRECT REACTION MIX
- SIMPLEXA CONGENITAL CMV POSITIVE CONTROL PACK
- SIMPLEXA DIRECT AMPLIFICATION DISC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.