Medical device licence · 89274 · Class 3
RESPONSE READER ADVANCED SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 17, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89274
- Licence holder
- Response Biomedical CorporationVancouver, BC, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 17, 2012
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RESPONSE READER ADVANCED SYSTEM - RAMP 200 CONTROL MODULE (CM)
- RESPONSE READER ADVANCED SYSTEM - RAMP 200 TEST MODULE (TM)
- RESPONSE READER ADVANCED SYSTEM - RAMP CARDIAC CALVER CONTROLS
- RESPONSE READER ADVANCED SYSTEM - RAMP CARDIAC CONTROLS
- RESPONSE READER ADVANCED SYSTEM - RAMP CK-MB ASSAY
- RESPONSE READER ADVANCED SYSTEM - RAMP MYOGLOBIN ASSAY
- RESPONSE READER ADVANCED SYSTEM - RAMP NT-PROBNP ASSAY
- RESPONSE READER ADVANCED SYSTEM - RAMP TROPONIN I ASSAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.