Medical device licence · 38982 · Class 2
FOLATE TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 38982
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 11, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS FOLATE
- ELECSYS FOLATE III
- FOLATE III CALSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.