Medical device licence · 63224 · Class 2
IMX SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 14, 2003; ended October 25, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63224
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 14, 2003
- Ended
- October 25, 2010
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMX SYSTEM - FREE T4 REAGENT
- IMX SYSTEM - B12 REAGENT
- IMX SYSTEM - BETA-HCG REAGENT
- IMX SYSTEM - DIGOXIN REAGENT
- IMX SYSTEM - ESTRADIOL REAGENT
- IMX SYSTEM - FERRITIN REAGENT
- IMX SYSTEM - FOLATE REAGENTS
- IMX SYSTEM - FREE T3 REAGENT
- IMX SYSTEM - FSH REAGENTS
- IMX SYSTEM - GLYCATED HEMOGLOBIN II ASSAY
- IMX SYSTEM - GLYCATED HEMOGLOBIN REAGENT
- IMX SYSTEM - HAVAB REAGENT
- IMX SYSTEM - HAVAB-M REAGENT
- IMX SYSTEM - HCG REAGENT
- IMX SYSTEM - IMX ANALYZER - CLASS 2
- IMX SYSTEM - LH REAGENT
- IMX SYSTEM - METABOLIC ASSAY SOFTWARE MODULE
- IMX SYSTEM - PAP REAGENT
- IMX SYSTEM - RF NEUTRAL REAGENT
- IMX SYSTEM - SELECT PROLACTIN REAGENT
- IMX SYSTEM - T-UPTAKE REAGENT
- IMX SYSTEM - T3 REAGENT
- IMX SYSTEM - T4 REAGENT
- IMX SYSTEM - THEOPHYLLINE REAGENT
- IMX SYSTEM - ULTRASENSITIVE HTSH II REAGENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.