Medical device licence · 102554 · Class 3
COBAS CT/NG
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102554
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 19, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 6800/8800 BUFFER NEGATIVE CONTROL KIT
- COBAS BUFFER NEGATIVE CONTROL KIT
- COBAS CT/NG
- COBAS CT/NG POSITIVE CONTROL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.