Medical device licence · 102760 · Class 2
B2-MICROGLOBULIN
Yes: licensed in Canada
Licence status Issued (active); first licensed April 17, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102760
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 17, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- B2MG TINA-QUANT B2-MICROGLOBULIN
- CALIBRATOR B2-MICROGLOBULIN
- CONTROL SET B2-MICROGLOBULIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.