Medical device licence · 18860 · Class 3
COBAS CORE SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed March 29, 2000; ended July 23, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 18860
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 29, 2000
- Ended
- July 23, 2010
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CORE SYSTEM - ANALYZER - CLASS 3
- COBAS CORE SYSTEM - ANTI HSV I/II (HERPES)
- COBAS CORE SYSTEM - CMV IGG EIA RECOMB
- COBAS CORE SYSTEM - CMV IGM EIA RECOMB
- COBAS CORE SYSTEM - HSV-2 IGG EIA
- COBAS CORE SYSTEM - RUBELLA IGG
- COBAS CORE SYSTEM - RUBELLA IGG EIA RECOMB II ASSAY
- COBAS CORE SYSTEM - RUBELLA IGM
- COBAS CORE SYSTEM - TOXO IGG
- COBAS CORE SYSTEM - TOXO IGM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.