Medical device licence · 74414 · Class 2
CREATININE
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
- 74414
- 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
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS C 111 CREJ2 - CREATININE JAFFE
- COBAS C 111 CREP2 - CREATININE PLUS
- CREJ2 (CREATININE JAFFE GEN.2) FOR COBAS C701 ANALYZER
- CREJ2 (CREATININE JAFFÉ GEN. 2)
- CREP2 (CREATININE PLUS VER. 2)
- CREP2 (CREATININE PLUS 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.