Medical device licence · 2819 · Class 4
NAT ANALYZERS
No longer licensed: cancelled
Licence status Cancelled; first licensed May 4, 1999; ended May 5, 2026. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2819
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- May 4, 1999
- Ended
- May 5, 2026
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLICOR HCV SPECIMEN PREPARATION KIT
- COBAS AMPLICOR ANALYZER
- COBAS AMPLICOR DETECTION REAGENTS KIT
- COBAS AMPLICOR HCV DETECTION KIT
- COBAS AMPLICOR INTERNAL CONTROL DETECTION KIT
- COBAS AMPLICOR SYSTEM - COBAS AMPLICOR HCV DETECTION KIT
- COBAS AMPLICOR SYSTEM - GENERIC DETECTION KIT
- COBAS AMPLICOR SYSTEM - HCV DETECTION KIT
- COBAS AMPLICOR SYSTEM - HCV PREPARATION KIT
- COBAS AMPLICOR SYSTEM - HCV PREPARATION KIT
- COBAS AMPLICOR SYSTEM - INTERNAL CONTROL DETECTION KIT
- COBAS AMPLICOR SYSTEM ANALYZER - CLASS 4
- COBAS AMPLICOR VERSION 0022B
- COBAS AMPLICOR WASH BUFFER
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- COBAS TAQMAN 48 ANALYZER
- COBAS TAQMAN ANALYZER (96)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.