Medical device licence · 86403 · Class 3
GSP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86403
- Licence holder
- Wallac OyTurku, Finland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 22, 2011
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GSP - CLEAR MICROPLATE
- GSP - DELFIA INDUCER
- GSP - GENETIC SCREENING PROCESSOR
- GSP - NEONATAL 17ALPHA-OHPROGESTERONE KIT
- GSP - NEONATAL GALT KIT
- GSP - NEONATAL HTSH KIT
- GSP - NEONATAL IRT KIT
- GSP - NEONATAL THYROXINE (T4) KIT
- GSP - WASH CONCENTRATE
- GSP NEONATAL BIOTINIDASE KIT
- GSP NEONATAL CREATINE KINASE -MM KIT
- GSP NEONATAL TOTAL GALACTOSE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.