Medical device licence · 8583 · Class 3
QUANTITATIVE HBV NAT KITS
No longer licensed: cancelled
Licence status Cancelled; first licensed July 29, 1999; ended May 5, 2026. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 8583
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- July 29, 1999
- Ended
- May 5, 2026
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPLICOR QUANTITATIVE HBV MONITOR TEST
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST VERSION 2.0
- COBAS TAQMAN HBV TEST
- HBV MONITOR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.