Medical device licence · 10519 · Class 4
ABBOTT PRISM SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed September 9, 1999; ended November 18, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 10519
- Licence holder
- Abbott GmbhWiesbaden, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 9, 1999
- Ended
- November 18, 2022
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRISM HBC ASSAY SYSTEM
- PRISM SYSTEM - ANALYZER - CLASS 4
- PRISM SYSTEM - HBCORE ASSAY (DONOR SCREENING)
- PRISM SYSTEM - HBSAG ASSAY (DONOR SCREENING)
- PRISM SYSTEM - HBSAG CONFIRMATION ASSAY
- PRISM SYSTEM - HCV ASSAY (DONOR SCREENING)
- PRISM SYSTEM - HIV O PLUS (DONOR SCREENING)
- PRISM SYSTEM - HIV-1/HIV-2 ASSAY (DONOR SCREENING)
- PRISM SYSTEM - HTLV-1/HTLV-II ASSAY (DONOR SCREENING)
- PRISM SYSTEM - INSTRUMENT REAGENTS
- PRISM SYSTEM - RUN CONTROLS
- PRISM SYSTEM, HBSAG CONFIRMATORY ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.