Medical device licence · 76399 · Class 2
RHEUMATOID FACTOR (RF)
Yes: licensed in Canada
Licence status Issued (active); first licensed February 19, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76399
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 19, 2008
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA RHEUMATOID FACTORS II (RF-II)
- HITACHI RF CONTROL SET
- HITACHI/COBAS INTEGRA PRECISET RF
- RF-II (RHEUMATOID FACTORS II)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.