Medical device licence · 76396 · Class 2
APOLIPOPROTEIN A-1
Yes: licensed in Canada
Licence status Issued (active); first licensed February 19, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76396
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 19, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA TINA-QUANT APOLIPOPROTEIN A VER.2 (APOAT)
- HITACHI TINA-QUANT APOLIPOPROTEIN A1 VER.2(APO A1 VER.2)
- TINA QUANT APOAT (APOLIPOPROTEIN A-1 VER. 2) FOR COBAS C701 ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.