Medical device licence · 101061 · Class 3
COBAS 4800 CMV
Yes: licensed in Canada
Licence status Issued (active); first licensed May 18, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101061
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- May 18, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 4800 CMV
- COBAS 4800 CMV CONTROL KIT
- COBAS 4800 SYSTEM LYSIS KIT 2
- COBAS 4800 SYSTEM SAMPLE PREPARATION KIT 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.