Medical device licence · 96090 · Class 2
COBAS C 513 ANALYZER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 17, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96090
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 17, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- A1CD HEMOLYZING REAGENT
- A1CX3 TINA-QUANT HEMOGLOBIN A1CDX GEN.3
- AICX4 TINA-QUANT HEMOGLOBIN A1C DX IV
- COBAS C 513 ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.