ApprovalTrail

Medical device licence · 115753 · Class 4

ACCESS ANTI-HBE

Yes: licensed in Canada

Licence status Issued (active); first licensed July 10, 2026. It is in Health Canada’s list of active licences.
Licence number
115753
Licence holder
Beckman Coulter, Inc.San Diego, CA, United States
Risk class
Class IV (highest risk)
Licence type
Test Kit
First licensed
July 10, 2026
Devices covered
3

Devices on this licence

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

  • ACCESS ANTI-HBE
  • ACCESS ANTI-HBE CALIBRATOR
  • ACCESS ANTI-HBE QC

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