Medical device licence · 65311 · Class 3
NUCLEIC ACID TESTING ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 4, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65311
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- August 4, 2004
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LIGHT CYCLER 2.0 INSTRUMENT V.4.05 IVD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.