Medical device licence · 74379 · Class 2
HEMOGLOBIN A1C (HBA1C)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 4, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74379
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 4, 2007
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- A1C-3 (TINA-QUANT HEMOGLOBIN A1C GEN.3)
- A1CX3 TINA-QUANT HEMOGLOBIN A1CDX GEN.3
- AICX4 TINA-QUANT HEMOGLOBIN A1C DX IV
- C.F.A.S. HBA1C
- HBA1C III (TINA-QUANT HEMOGLOBIN A1C III)
- HITACHI TINA-QUANT HEMOGLOBIN A1C II (HBA1C)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.