Medical device licence · 64987 · Class 3
QUANTITATIVE HIV NAT KITS
No longer licensed: cancelled
Licence status Cancelled; first licensed July 5, 2004; ended May 11, 2006. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 64987
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- July 5, 2004
- Ended
- May 11, 2006
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST KIT
- COBAS TAQMAN HIV-1 TEST
- HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT (FOR SAMPLE PREPARATION)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.