ApprovalTrail

Medical device licence · 104564 · Class 3

DIGIVAL

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed April 23, 2020; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
104564
Licence holder
Abbott Diagnostics Scarborough, Inc.Scarborough, ME, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 23, 2020
Ended
December 9, 2025
Devices covered
6

Devices on this licence

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

  • ALERE READER
  • ALERE READER BINAXNOW TRAY PACK
  • ALERE READER CALIBRATION CHECK CARD PACK
  • DIGIVAL
  • DIGIVAL CALIBRATION CHECK CARD PACK
  • DIGIVAL TRAY 1 PACK

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