Medical device licence · 80345 · Class 2
AMPHETAMINES ASSAY
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80345
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 31, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMPS2 (AMPHETAMINES II)
- AMPS2 (ONLINE DAT AMPHETAMINES II)
- ONLINE DAT AMPHETAMINES II FOR COBAS INTEGRA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.