ApprovalTrail

Medical device licence · 36847 · Class 2

CHOLESTEROL

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed March 18, 2002; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
36847
Licence holder
Randox Laboratories Ltd.Crumlin, AT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
March 18, 2002
Ended
December 9, 2025
Devices covered
7

Devices on this licence

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

  • CHOLESTEROL (CHOL) ENZYMATIC FOR HITACHI 917/HITACHI MODULAR P
  • CHOLESTEROL (LIQUID) - ENZYMATIC
  • CHOLESTEROL (LIQUID) - ENZYMATIC FOR HITACHI 717/911/912/747
  • CHOLESTEROL - ENZYMATIC ENDPOINT METHOD KIT FOR USE ON HITACHI 704, 717, 902 AND 911/912 ANALYSERS
  • CHOLESTEROL - ENZYMATIC FOR DIMENSION
  • CHOLESTEROL - ENZYMATIC FOR RX DAYTONA
  • CHOLESTEROL - ENZYMATIC FOR SYNCHRON CX 4/5/7/9 & SYNCHRON LX 20

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