Medical device licence · 80091 · Class 2
D-DIMER (D-DI)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 3, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80091
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 3, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-DI2 (TINA-QUANT D-DIMER GEN.2)
- TINA-QUANT D-DIMER GEN.2 (D-DI2) FOR USE ON COBAS C701 ANALYZER
- TINA-QUANT D-DIMER GEN.2 FOR ROCHE COBAS C 111 ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.