ApprovalTrail

Medical device licence · 63322 · Class 2

EVIDENCE SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed December 1, 2003; ended October 13, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
63322
Licence holder
Randox Laboratories Ltd.Crumlin, AT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
December 1, 2003
Ended
October 13, 2020
Devices covered
17

Devices on this licence

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

  • EVIDENCE SYSTEM - ANALYSER
  • EVIDENCE SYSTEM - BULK REAGENTS
  • EVIDENCE SYSTEM - CYTOKINE
  • EVIDENCE SYSTEM - DRUGS OF ABUSE
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY 1 ORAL FLUID
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY 1 ORAL FLUID CALIBRATORS
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY 1 ORAL FLUID CONTROLS
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY I (URINE SEMI-QUANT.) (DOA I URN SO)
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY I BLOOD SEMI-QUANTITATIVE (DOA I WB SQ)
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY I CALIBRATOR
  • EVIDENCE SYSTEM - DRUGS OF ABUSE ARRAY II (WHOLE BLOOD) (DOA II WB)
  • EVIDENCE SYSTEM - DRUGS OF ABUSE II (WHOLE BLOOD) MULTI-ANALYTE CALIBRATORS
  • EVIDENCE SYSTEM - DRUGS OF ABUSE II BLOOD CONTROLS
  • EVIDENCE SYSTEM - FERTILITY
  • EVIDENCE SYSTEM - FERTILITY HORMOME ARRAY (FERT)
  • EVIDENCE SYSTEM - THYROID (FREE)
  • EVIDENCE SYSTEM - THYROID (TOTAL)

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “evidence”. A notice may cover another product or only some lots: read it to see what it covers.

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