ApprovalTrail

Medical device licence · 99005 · Class 2

XPERT XPRESS FLU/RSV

Yes: licensed in Canada

Licence status Issued (active); first licensed April 20, 2017. It is in Health Canada’s list of active licences.
Licence number
99005
Licence holder
CepheidSunnyvale, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
April 20, 2017
Devices covered
3

Devices on this licence

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

  • XPERT NASAL SAMPLE COLLECTION KIT
  • XPERT NASOPHARYNGEAL SAMPLE COLLECTION KIT
  • XPERT XPRESS FLU/RSV

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