Medical device licence · 101269 · Class 3
ACCESS HSTNI ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101269
- Licence holder
- Immunotech S.A.S., A Beckman Coulter CompanyMarseille Cedex 09, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- June 22, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS HSTNI
- ACCESS HSTNI CALIBRATORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.