ApprovalTrail

Medical device licence · 102235 · Class 2

QUANTA FLASH RF IGM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 4, 2019. It is in Health Canada’s list of active licences.
Licence number
102235
Licence holder
Inova Diagnostics IncSan Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
January 4, 2019
Devices covered
3

Devices on this licence

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

  • QUANTA FLASH RF IGM CALIBRATORS
  • QUANTA FLASH RF IGM CONTROLS
  • QUANTA FLASH RF IGM REAGENTS

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