Medical device licence · 98375 · Class 2
QUANTA FLASH LKM-1
Yes: licensed in Canada
Licence status Issued (active); first licensed January 17, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98375
- Licence holder
- Inova Diagnostics IncSan Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 17, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- QUANTA FLASH LKM-1 CALIBRATORS
- QUANTA FLASH LKM-1 CONTROLS
- QUANTA FLASH LKM-1 REAGENTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.