Medical device licence · 65674 · Class 2
C-PEPTIDE TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 30, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65674
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 30, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS C-PEPTIDE
- ELECSYS C-PEPTIDE ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.