Medical device licence · 2488 · Class 3
COBAS AMPLICOR SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed September 1, 1999; ended May 12, 2006. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2488
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 1, 1999
- Ended
- May 12, 2006
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS AMPLICOR - ANALYZER - CLASS 3
- COBAS AMPLICOR - CHLAMYDIA TRACHOMATIS DETECTION KIT
- COBAS AMPLICOR - MYCOBACTERIUM TUBERCULOSIS DETECTION ASSAY
- COBAS AMPLICOR - NEISSERIA GONORRHOEAE DETECTION ASSAY
- COBAS AMPLICOR ANALYZER - CLASS 3
- COBAS AMPLICOR CHLAMYDIA TRACHOMATIS DETECTION KIT
- COBAS AMPLICOR HCV DETECTION KIT
- COBAS AMPLICOR HCV MONITOR TEST V2.0
- COBAS AMPLICOR HIV MONITOR TEST V1.5
- COBAS AMPLICOR MYCOBACTERIUM TUBERCULOSIS DETECTION KIT
- COBAS AMPLICOR NEISSERIA GONORRHOEAE DETECTION KIT
- COBAS AMPLICOR VERSION 0022B
- COBAS AMPLICOR/COBAS AMPLIPREP HCV-1 MONITOR ULTRASENSATIVE TEST V2.0
- COBAS AMPLIPREP/COBAS AMPLICOR HIV-1 MONITOR V1.5
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.