Medical device licence · 85585 · Class 2
AMIKACIN
No longer licensed: cancelled
Licence status Cancelled; first licensed March 23, 2011; ended September 18, 2025. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 85585
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 23, 2011
- Ended
- September 18, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMIK2 ONLINE TDM AMIKACIN FOR COBAS C SYSTEMS
- AMIKACIN (AMIK2) FOR USE ON COBRAS C SYSTEMS
- AMIKACIN (ONLINE TDM AMIKACIN) FOR USE ON ROCHE/HITACHI 911/912/917 AND MODULAR P ANALYZERS
- AMIKACIN FOR USE ON COBAS INTEGRA ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.