Medical device licence · 9176 · Class 4
IMX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 3, 1999; ended October 24, 2011. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 9176
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- August 3, 1999
- Ended
- October 24, 2011
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMX HBSAG V2 REAGENT
- IMX SYSTEM - AUSAB ASSAY
- IMX SYSTEM - CORE M ASSAY
- IMX SYSTEM - HBE 2 ASSAY
- IMX SYSTEM - HBSAG ASSAY (DONOR SCREENING)
- IMX SYSTEM - HBSAG CONFIRMATORY ASSAY
- IMX SYSTEM - HCV ASSAY
- IMX SYSTEM - HCV VERSION 3.0 ASSAY (DONOR SCREENING)
- IMX SYSTEM - HEPATITIS B VIRUS CORE ANTI ASSAY
- IMX SYSTEM - IMMUNOASSAY ANALYZER - CLASS 4
- IMX SYSTEM ANTI-HBE 2 ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.