Medical device licence · 4626 · Class 3
AXSYM SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed June 14, 1999; ended June 29, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 4626
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 14, 1999
- Ended
- June 29, 2015
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXSYM AFP REAGENT PACK
- AXSYM CEA REAGENT PACK
- AXSYM CKMB REAGENT PACK
- AXSYM CMV IGG REAGENT PACK
- AXSYM CMV IGM 2.0 REAGENT
- AXSYM CYCLOSPORINE REAGENT PACK
- AXSYM FREE PSA REAGENT PACK
- AXSYM IMMUNOASSAY ANALYZER CLASS 3
- AXSYM MYOGLOBIN REAGENT
- AXSYM PSA REAGENT PACK
- AXSYM RUBELLA IGG REAGENT PACK
- AXSYM RUBELLA IGM REAGENT PACK
- AXSYM SYSTEM - CA 15-3 ASSAY
- AXSYM SYSTEM - CA-125 ASSAY
- AXSYM SYSTEM - CEA ASSAY
- AXSYM SYSTEM - TROPONIN-I ADV ASSAY
- AXSYM TOTAL PSA REAGENT PACK
- AXSYM TOXO IGG REAGENT PACK
- AXSYM TOXO IGM REAGENT PACK
- AXSYM TROPONIN-I REAGENT PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.