Medical device licence · 72316 · Class 3
IMDX SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed September 11, 2006; ended October 31, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 72316
- Licence holder
- Qvella CorporationRichmond Hill, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 11, 2006
- Ended
- October 31, 2016
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMDX 9600 SYSTEM - IMDX PREP ANALYZER HARDWARE
- IMDX 9600 SYSTEM - IMDX PREP INSTRUMENT SOLUTIONS
- IMDX 9600 SYSTEM - IMDX PREP ISE CALIBRATORS
- IMDX 9600 SYSTEM - IMDX PREP MMT REACTION PLATE
- IMDX 9600 SYSTEM - IMDX PREP MMT-I DOA CALIBRATION PLATE
- IMDX 9600 SYSTEM - IMDX PREP MMT-I DOA CONTROL
- IMDX 9600 SYSTEM - IMDX PREP MMT-I DOA REAGENT PLATE
- IMDX 9600 SYSTEM - INSTRUMENT
- IMDX SYSTEM - IMDX ANALYZER
- IMDX SYSTEM - IMDX PREP MMT-1 CALIBRATION PLATE
- IMDX SYSTEM - IMDX PREP MMT-1 CONTROL
- IMDX SYSTEM - IMDX PREP MMT-1 REAGENT PLATE
- IMDX SYSTEM - IMDX PREP REACTION PLATE
- IMDX SYSTEM - IMDXPREP MMT-5 CALIBRATION PLATE
- IMDX SYSTEM - IMDXPREP MMT-5 CONTROL
- IMDX SYSTEM - IMDXPREP MMT-5 REAGENT PLATE
- IMDX SYSTEM - IMDXPREP MMT-6 CALIBRATION PLATE
- IMDX SYSTEM - IMDXPREP MMT-6 CONTROL
- IMDX SYSTEM - IMDXPREP MMT-6 REAGENT PLATE
- IMDX SYSTEM - PREP ANALYZER HARDWARE
- IMDX SYSTEM - PREP INSTRUMENT SOLUTIONS
- IMDX SYSTEM - PREP ISE CALIBRATORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.