ApprovalTrail

Medical device licence · 39021 · Class 2

DIGITOXIN TEST KIT

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed November 27, 2001; ended October 31, 2019. It is in Health Canada’s archive of licences no longer in force.
Licence number
39021
Licence holder
Roche Diagnostics GmbhMannheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
November 27, 2001
Ended
October 31, 2019
Devices covered
4

Devices on this licence

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

  • DIGIT (ONLINE TDM DIGITOXIN) FOR COBAS C SYSTEMS
  • DIGITOXIN (DIGIT)
  • ELECSYS DIGITOXIN
  • ONLINE TDM DIGITOXIN FOR HITACHI 911, 912, 917 AND MODULAR P ANALYZERS

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