Medical device licence · 82078 · Class 2
IGM (IMMUNOGLOBULIN M)
Yes: licensed in Canada
Licence status Issued (active); first licensed February 18, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82078
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 18, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IGM-2 (TINA-QUANT IGM GEN.2)
- IMMUNOGLOBULIN M FOR USE ON COBAS INTEGRA 400/400 PLUS/800 ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.