ApprovalTrail

Medical device licence · 63489 · Class 2

GLUCOSE - HEXOKINASE

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed January 9, 2004; ended October 28, 2022. It is in Health Canada’s archive of licences no longer in force.
Licence number
63489
Licence holder
Randox Laboratories Ltd.Crumlin, AT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
January 9, 2004
Ended
October 28, 2022
Devices covered
7

Devices on this licence

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

  • GLUCOSE BY HEXOKINASE MANUAL METHOD
  • GLUCOSE HEXOKINASE FOR BECKMAN SYNCHRON
  • GLUCOSE HEXOKINASE FOR DIMENSION
  • GLUCOSE HEXOKINASE FOR HITACHI 704, 717, 902, 911/912
  • GLUCOSE HEXOKINASE FOR HITACHI 717, 911/912
  • GLUCOSE HEXOKINASE FOR HITACHI 747 - HITACHI MODULAR D
  • GLUCOSE HEXOKINASE FOR HITACHI 917 (USER DEFINED)

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