Medical device licence · 100862 · Class 2
AMH PMAX EIA
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed April 16, 2018; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 100862
- Licence holder
- Paramax Diagnostics Inc.Thornhill, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 16, 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 PMAX ASSAY BUFFER
- AMH PMAX ASSAY BUFFER B
- AMH PMAX BIOTIN REAGENT
- AMH PMAX CALIBRATOR A
- AMH PMAX CALIBRATOR B
- AMH PMAX CALIBRATOR C
- AMH PMAX CALIBRATOR D
- AMH PMAX CALIBRATOR E
- AMH PMAX CALIBRATOR F
- AMH PMAX EIA
- AMH PMAX ENZYME REAGENT (RTU)
- PMAX MICROTITRATION STRIPS AMH
- PMAX STOP SOLUTION
- PMAX SUBSTRATE REAGENT
- PMAX WASH CONCENTRATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.