ApprovalTrail

Medical device licence · 103289 · Class 2

CD16

Yes: licensed in Canada

Licence status Issued (active); first licensed July 19, 2019. It is in Health Canada’s list of active licences.
Licence number
103289
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 19, 2019
Devices covered
10

Devices on this licence

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

  • CD16 FREEZE-DRIED
  • CD16-APC
  • CD16-APC -ALEXA FLUOR 700
  • CD16-APC -ALEXA FLUOR 750
  • CD16-ECD
  • CD16-FITC
  • CD16-KROME ORANGE
  • CD16-PACIFIC BLUE
  • CD16-PC5
  • CD16-PE

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