Medical device licence · 76873 · Class 2
ISE CALIBRATION SOLUTIONS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76873
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 18, 2008
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS ISE INTERNAL STANDARD GEN.2
- ISE CALIBRATION KIT FOR COBAS C 111 SYSTEM
- ISE CALIBRATOR DIRECT
- ISE CALIBRATOR INDIRECT/URINE
- ISE CALIBRATOR INDIRECT/URINE FOR COBAS C 111 SYSTEM
- ISE INTERNAL STANDARD GEN.2
- ISE INTERNAL STANDARD GEN.2 CONC.
- ISE REFERENCE ELECTROLYTE
- ISE REFERENCE ELECTROLYTE
- ISE REFERENCE SOLUTION FOR COBAS C 111 SYSTEM
- ROCHE HITACHI ISE STANDARDS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.