Medical device licence · 80992 · Class 2
OC-SENSOR DIANA IFOB TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 23, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80992
- Licence holder
- Eiken Chemical Co., Ltd.Chiyoda-Ku, 13, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 23, 2009
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OC-SENSOR DIANA IFOB TEST SYSTEM - ANALYZER
- OC-SENSOR DIANA IFOB TEST SYSTEM - BUFFER
- OC-SENSOR DIANA IFOB TEST SYSTEM - LATEX REAGENT
- OC-SENSOR DIANA IFOB TEST SYSTEM - WASH CONCENTRATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.