Medical device licence · 112692 · Class 2
ALLPLEX CANDIDIASIS ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed February 11, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112692
- Licence holder
- Seegene Inc.Seoul, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 11, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALLPLEX CANDIDIASIS ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.