Medical device licence · 38530 · Class 3
FREE PSA TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 18, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 38530
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- January 18, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS FREE PSA
- ELECSYS FREE PSA ASSAY (NEW FORMULATION)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.