Medical device licence · 101133 · Class 2
SERA-AMH EIA
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed May 29, 2018; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101133
- Licence holder
- Seranostics Inc.Thornhill, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 29, 2018
- Ended
- November 1, 2021
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMH ASSAY BUFFER
- AMH ASSAY BUFFER B
- AMH BIOTIN REAGENT
- AMH CALIBRATOR A
- AMH CALIBRATOR B
- AMH CALIBRATOR C
- AMH CALIBRATOR D
- AMH CALIBRATOR E
- AMH CALIBRATOR F
- AMH ENZYME REAGENT
- AMH PLATE
- SERA-AMH 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.