Medical device licence · 38736 · Class 3
MYOGLOBIN TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed May 31, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 38736
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 31, 2001
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MYO2 TINA-QUANT MYOGLOBIN GEN.2
- TINA-QUANT MYOGLOBIN GEN 2 FOR COBAS INTEGRA AND COBAS C501
- TINA-QUANT MYOGLOBIN GEN 2 FOR ROCHE HITACHI
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.