Medical device licence · 76863 · Class 2
PHENYTOIN
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76863
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 18, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA PHENYTOIN (PHNY)
- COBAS-FP FREE PHENYTOIN CONTROLS
- PHNY2 (ONLINE TDM PHENYTOIN)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.