Medical device licence · 76414 · Class 2
ALCOHOL ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed February 20, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76414
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 20, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS C 111 C-ETHANON (ETOH2) ASSAY
- ETOH2 (ETHANOL GEN. 2) FOR ROCHE / HITACHI COBAS C / COBAS C 701
- ETOH2 (ETHANOL GEN.2)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.