Medical device licence · 38084 · Class 4
HBSAG TEST KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 28, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 38084
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- January 28, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELECSYS HBSAG CONFIRMATORY TEST
- ELECSYS HBSAG II
- ELECSYS HBSAG II (DONOR SCREENING)
- ELECSYS HBSAG II AUTO CONFIRM
- PRECICONTROL HBSAG AUTO CONFIRM
- PRECICONTROL HBSAG II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.