ApprovalTrail

Medical device licence · 104744 · Class 2

QUANTA FLASH INTRINSIC FACTOR

Yes: licensed in Canada

Licence status Issued (active); first licensed June 5, 2020. It is in Health Canada’s list of active licences.
Licence number
104744
Licence holder
Inova Diagnostics IncSan Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
June 5, 2020
Devices covered
3

Devices on this licence

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

  • QUANTA FLASH INTRINSIC FACTOR CALIBRATORS
  • QUANTA FLASH INTRINSIC FACTOR CONTROLS
  • QUANTA FLASH INTRINSIC FACTOR REAGENTS

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