Medical device licence · 74390 · Class 2
AMYLASE
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
- 74390
- 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
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMYL2 (ALPHA-AMYLASE EPS VER.2)
- AMYL2 (ALPHA-AMYLASE EPS VER.2) FOR COBAS C701 ANALYZER
- COBAS C 111 A-AMYLASE (AMYL2)
- HITACHI ALPHA-AMYLASE LIQUID ACC. TO IFCC (AMYL)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.