Medical device licence · 74371 · Class 2
CK-NAC
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 74371
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 5, 2007
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CK (CREATINE KINASEA) FOR COBAS C701 ANALYZER
- COBAS C 111 CREATINE KINASE (CKL)
- COBAS INTEGRA CREATININE KINASE CKL
- HITACHI CREATINE KINASE LIQUID, ACC. TO IFCC (CK)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.