ApprovalTrail

Medical device licence · 78767 · Class 3

RUBELLA IGM TEST KITS

Yes: licensed in Canada

Licence status Issued (active); first licensed January 7, 2009. It is in Health Canada’s list of active licences.
Licence number
78767
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
January 7, 2009
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ELECSYS RUBELLA IGM
  • PRECICONTROL RUBELLA IGM

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.