Medical device licence · 107061 · Class 2
DXU MICROSCOPY SERIES IRIS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 30, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107061
- Licence holder
- Beckman Coulter Ireland, Inc.Co. Clare, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 30, 2021
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DXU 840M IRIS
- DXU 850M IRIS
- IQ BODY FLUID LYSING REAGENT
- IQ BODY FLUIDS CONTROLS
- IQ CALIBRATOR
- IQ CONTROL
- IQ LAMINA
- IQ PRECISION KIT
- IRIS DILUENT
- IRIS SYSTEM CLEANSER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.