Medical device licence · 10648 · Class 4
MONOLISA HBC IGM EIA
No longer licensed: cancelled
Licence status Cancelled; first licensed August 25, 1999; ended April 21, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 10648
- Licence holder
- Bio-RadMarnes-La-Coquette, 51, France
- Risk class
- Class IV (highest risk)
- Licence type
- Test Kit
- First licensed
- August 25, 1999
- Ended
- April 21, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MONOLISA HBC IGM EIA
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “monolisa”. A notice may cover another product or only some lots: read it to see what it covers.
- Monolisa Hcv Ag-Ab Ultra V2December 14, 2023 · Microbiology · Performance · Type II
- Monolisa Hcv Ag-Ab Ultra V2March 31, 2017 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.