Medical device licence · 83919 · Class 2
HAPTOGLOBIN TEST KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 13, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83919
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 13, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HAPT2 (TINA-QUANT HAPTOGLOBIN VER.2)
- HAPT2 (TINA-QUANT HAPTOGLOBIN VER.2) FOR ROCHE/HITACHI COBAS C ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.