ApprovalTrail

Medical device licence · 101262 · Class 2

SERA-FT4 EIA

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed June 19, 2018; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
101262
Licence holder
Seranostics Inc.Thornhill, ON, Canada
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
June 19, 2018
Ended
November 1, 2021
Devices covered
8

Devices on this licence

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

  • FT4 CALIBRATOR
  • FT4 ENZYME REAGENT
  • FT4 PLATE
  • SERA-FT4 EIA
  • STOP SOLUTION
  • SUBSTRATE REAGENT A
  • SUBSTRATE REAGENT B
  • WASH CONCENTRATE

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