Medical device licence · 74386 · Class 2
ALBUMIN TEST KITS
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
- 74386
- 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
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALB2 (ALBUMIN GEN. 2) FOR COBAS C701 ANALYZER
- ALB2 (ALBUMIN GEN.2)
- ALBP (ALBUMIN BCP)
- ALBT2 (TINA-QUANT ALBUMIN GEN. 2) FOR COBAS C701 ANALYZER
- COBAS C 111 ALBT2 (TINA-QUANT)
- COBAS C 111 ALBUMIN (ALB2)
- START (ANTIGEN EXCESS REAGENT) FOR COBAS C701 ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.