Medical device licence · 101536 · Class 2
SERA-PCT EIA
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed July 31, 2018; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101536
- Licence holder
- Seranostics Inc.Thornhill, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 31, 2018
- Ended
- November 1, 2021
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PCT CALIBRATOR A
- PCT CALIBRATOR B
- PCT CALIBRATOR C
- PCT CALIBRATOR D
- PCT CALIBRATOR E
- PCT CALIBRATOR F
- PCT ENZYME REAGENT
- PCT PLATE
- SERA-PCT EIA
- STOP SOLUTION
- SUBSTRATE REAGENT N
- WASH CONCENTRATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.