Medical device licence · 9724 · Class 3
IMX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 26, 1999; ended October 25, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 9724
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 26, 1999
- Ended
- October 25, 2010
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABBOTT IMX CEA REAGENT PACK
- IMX SYSTEM - AFP REAGENT
- IMX SYSTEM - CA 125 REAGENT
- IMX SYSTEM - CA15-3 REAGENT
- IMX SYSTEM - CMV IGG REAGENT
- IMX SYSTEM - CMV IGM REAGENT PACK
- IMX SYSTEM - FREE PSA REAGENT
- IMX SYSTEM - IMMUNOASSAY ANALYZER - CLASS 3
- IMX SYSTEM - PSA REAGENT
- IMX SYSTEM - RUBELLA IGG REAGENT
- IMX SYSTEM - RUBELLA IGM REAGENT
- IMX SYSTEM - SELECT CHLAMYDIA REAGENT
- IMX SYSTEM - STAT CK-MB REAGENT PACK
- IMX SYSTEM - TACROLIMUS II W/A
- IMX SYSTEM - TACROLIMUS REAGENT
- IMX SYSTEM - TOTAL PSA REAGENT
- IMX SYSTEM - TOXO IGG REAGENT
- IMX SYSTEM - TOXO IGM REAGENT
- IMX SYSTEM - TOXO-IGG REAGENT
- IMX SYSTYEM - TOXO-IGM REAGENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.