Medical device licence · 2817 · Class 4
COBAS CORE SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed May 14, 1999; ended May 5, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2817
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- May 14, 1999
- Ended
- May 5, 2010
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS CORE ANALYZER - CLASS 4
- COBAS CORE ANALYZER - CLASS 4
- COBAS CORE SYSTEM - ANTI-HBE
- COBAS CORE SYSTEM - ANTI-HBC
- COBAS CORE SYSTEM - ANTI-HBC
- COBAS CORE SYSTEM - ANTI-HBC IGM
- COBAS CORE SYSTEM - ANTI-HBC IGM
- COBAS CORE SYSTEM - ANTI-HBE
- COBAS CORE SYSTEM - ANTI-HBS (QUALITATIVE)
- COBAS CORE SYSTEM - ANTI-HBS (QUALITATIVE)
- COBAS CORE SYSTEM - ANTI-HBS (QUANTITATIVE)
- COBAS CORE SYSTEM - ANTI-HBS (QUANTITATIVE)
- COBAS CORE SYSTEM - ANTI-HCV (DONOR SCREENING)
- COBAS CORE SYSTEM - ANTI-HCV (DONOR SCREENING)
- COBAS CORE SYSTEM - ANTI-HCV EIA II (DONOR SCREENING)
- COBAS CORE SYSTEM - ANTI-HTLV-1/2
- COBAS CORE SYSTEM - ANTI-HTLV-I/II (DONOR SCREENING)
- COBAS CORE SYSTEM - HBEAG
- COBAS CORE SYSTEM - HBEAG
- COBAS CORE SYSTEM - HBSAG
- COBAS CORE SYSTEM - HBSAG (CONFIRMATORY)
- COBAS CORE SYSTEM - HBSAG (CONFIRMATORY)
- COBAS CORE SYSTEM - HBSAG II EIA (DONOR SCREENING)
- COBAS CORE SYSTEM - SOFTWARE
- COBAS CORE SYSTEM - TMB SUBSTRATE KIT
- COBAS CORE SYSTEM - TMB SUBSTRATE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.