Medical device licence · 99930 · Class 3
ACCESS PAPP-A
Yes: licensed in Canada
Licence status Issued (active); first licensed October 30, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99930
- 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
- October 30, 2017
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS PAPP-A
- ACCESS PAPP-A CALIBRATORS
- ACCESS PAPP-A QC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.