Medical device licence · 62905 · Class 2
IMX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 25, 2003; ended October 25, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 62905
- Licence holder
- Abbott Japan Co., Ltd.Tokyo, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 25, 2003
- Ended
- October 25, 2010
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMX SYSTEM - BETA2-MICROGLOBULIN REAGENT
- IMX SYSTEM - CA19-9 REAGENT
- IMX SYSTEM - IGE REAGENT
- IMX SYSTEM - INSULIN REAGENT
- IMX SYSTEM - SCC REAGENT (SQUAMOUS CELL CARCINOMA ASSOCIATED ANTIGEN)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.