Medical device licence · 74397 · Class 3
CK-MB TEST KITS
No longer licensed: cancelled
Licence status Cancelled; first licensed July 4, 2007; ended July 15, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 74397
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- July 4, 2007
- Ended
- July 15, 2022
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- C.F.A.S. CK-MB FOR HITACHI AND COBAS INTEGRA
- CK MB FOR MODULAR P
- CK-MB
- CK-MB MPR1
- CK-MB STAT
- CKMB (CREATINE KINASE-MB)
- CKMBL FOR COBAS C111
- COBAS INTEGRA CREATINE KINASE-MB (CKMBL)
- ELECSYS CK-MB
- ELECSYS CK-MB (STAT)
- ELECSYS CK-MB CALSET
- ELECSYS CK-MB STAT CALSET
- HITACHI CK-MB
- HITACHI CREATININE KINASE-MB LIQUID (CK-MB)
- PRECINORM CK-MB FOR HITACHI AND COBAS INTEGRA
- PRECIPATH CK-MB FOR HITACHI AND COBAS INTEGRA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.