Medical device licence · 2139 · Class 4
AXSYM SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed September 14, 2000; ended June 29, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2139
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 14, 2000
- Ended
- June 29, 2015
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXSYM SYSTEM - ANTI-HBE 2.0 ASSAY
- AXSYM SYSTEM - ANTI-HBE ASSAY
- AXSYM SYSTEM - AXSYM HCV ASSAY (DONOR SCREENING)
- AXSYM SYSTEM - AXSYM HEPATITIS B AUSAB ASSAY
- AXSYM SYSTEM - AXSYM HEPATITIS B HBSAG ASSAY (DONOR SCREENING)
- AXSYM SYSTEM - CORE-M ASSAY
- AXSYM SYSTEM - HBE 2.0 ASSAY
- AXSYM SYSTEM - HBE REAGENT PACK
- AXSYM SYSTEM - HEPATITIS B CORE ASSAY
- AXSYM SYSTEM - HIV 1/2 G O ASSAY
- AXSYM SYSTEM - HIV AG/AB COMBO REAGENT
- AXSYM SYSTEM - HIV-1/HIV-2 (BLOOD DONOR SCREENING & DIAG PROCEDURE) ASSAY
- AXSYM SYSTEM - IMMUNOASSAY ANALYZER - CLASS 4
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.