Medical device licence · 82701 · Class 2
HBA1C CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 28, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82701
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 28, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRECICONTROL HBA1C NORM FOR COBAS C ANALYZERS AND COBRAS INTEGRA ANALYZERS
- PRECICONTROL HBA1C PATH FOR COBAS C ANALYZERS AND COBAS INTEGRA ANALYZERS
- PRECINORM HBA1C FOR ROCHE/HITACHI MODULAR ANALYZERS
- PRECIPATH HBA1C FOR ROCHE/HITACHI MODULAR ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.