Medical device licence · 112418 · Class 3
SIMPLEXA C. AURIS DIRECT
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112418
- Licence holder
- Diasorin Molecular LlcCypress, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 17, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECT AMPLIFICATION DISC KIT
- SIMPLEXA C. AURIS DIRECT
- SIMPLEXA C. AURIS POSITIVE CONTROL PACK
- SIMPLEXA C. AURIS SAMPLE PREP KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.