Medical device licence · 67006 · Class 3
GEM PCL PLUS SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 5, 2005; ended November 21, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 67006
- Licence holder
- Instrumentation Laboratory Co.Bedford, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 5, 2005
- Ended
- November 21, 2023
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM PCL PLUS SYSTEM - GEM TEST ACT CARTRIDGES
- GEM PCL PLUS SYSTEM - GEM TEST ACT-LR CARTRIDGES
- GEM PCL PLUS SYSTEM - GEM TEST APTT CATRIDGES
- GEM PCL PLUS SYSTEM - GEM TEST CITRATE PT CARTRIDGES
- GEM PCL PLUS SYSTEM - GEM TEST PT CARTRIDGES
- GEM PCL PLUS SYSTEM - INSTRUMENT
- GEM PCL PLUS SYSTEM - VERIFICATION CARTRIDGES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.