ApprovalTrail

Medical device licence · 86229 · Class 2

VANCOMYCIN ASSAYS

No longer licensed: cancelled

Licence status Cancelled; first licensed May 30, 2011; ended July 12, 2022. It is in Health Canada’s archive of licences no longer in force.
Licence number
86229
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
May 30, 2011
Ended
July 12, 2022
Devices covered
3

Devices on this licence

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

  • VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
  • VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 701/702 SYSTEMS
  • VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)

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