Medical device licence · 74393 · Class 2
BILIRUBIN DIRECT
Yes: licensed in Canada
Licence status Issued (active); first licensed July 4, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74393
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 4, 2007
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BILD2 (DIRECT BILIRUBIN GEN.2)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.