ApprovalTrail

Medical device licence · 10143 · Class 2

HEMATOLOGY ANALYZER

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 26, 1999; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
Licence number
10143
Licence holder
Beckman Coulter, Inc.San Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 26, 1999
Ended
December 6, 2024
Devices covered
11

Devices on this licence

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

  • COULTER LH 500 HEMATOLOGY ANALYZER
  • COULTER MAXM HEMATOLOGY ANALYZER
  • COULTER MAXM HEMATOLOGY ANALYZER W/AUTOLOADER AND RETICULOCYTE CAPABILITY
  • HMX HEMATOLOGY ANALYZER
  • HMX PAK REAGENT KIT
  • ISOTON 4 DILUENT
  • ISOTON III DILUENT
  • LH SERIES DILUENT
  • LH SERIES PAK REAGENT KIT
  • LYSE S 4 LYTIC REAGENT
  • LYSE S III DIFF LYTIC REAGENT

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