Medical device licence · 74383 · Class 2
LIPASE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 4, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74383
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 4, 2007
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS C 111 LIPASE (LIPC)
- HITACHI LIPASE COLORIMETRIC ASSAY (LIP)
- LIPC (LIPASE COLORIMETRIC) FOR COBAS C701 ANALYZER
- LIPC LIPASE COLORIMETRIC ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.