Medical device licence · 101296 · Class 2
SERA-FT3 EIA
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed June 25, 2018; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101296
- Licence holder
- Seranostics Inc.Thornhill, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 25, 2018
- Ended
- November 1, 2021
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FT3 CALIBRATOR
- FT3 ENZYME REAGENT
- FT3 PLATE
- SERA-FT3 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.