Medical device licence · 71150 · Class 3
QUANTITATIVE HCV NAT TEST KITS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed April 24, 2006; ended October 29, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 71150
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- April 24, 2006
- Ended
- October 29, 2015
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLICOR HCV MONITOR TEST V2.0
- COBAS AMPLICOR HCV MONITOR TEST V2.0
- COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
- COBAS TAQMAN HCV TEST
- COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.