Medical device licence · 102165 · Class 3
COBAS HPV
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102165
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 17, 2018
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS HPV
- COBAS HPV NEGATIVE CONTROL KIT
- COBAS HPV POSITIVE CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.