ApprovalTrail

Medical device licence · 103254 · Class 2

CD4

Yes: licensed in Canada

Licence status Issued (active); first licensed July 18, 2019. It is in Health Canada’s list of active licences.
Licence number
103254
Licence holder
Immunotech S.A.S., A Beckman Coulter CompanyMarseille Cedex 09, France
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
July 18, 2019
Devices covered
12

Devices on this licence

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

  • CD4 FREEZE DRIED
  • CD4-APC
  • CD4-APC -ALEXA FLUOR 700
  • CD4-APC -ALEXA FLUOR 750
  • CD4-BIOTIN FREEZE-DRIED
  • CD4-FITC
  • CD4-KROME ORANGE
  • CD4-PACIFIC BLUE
  • CD4-PC5
  • CD4-PC5.5
  • CD4-PE
  • CD4-SNV605

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