Medical device licence · 89638 · Class 4
GENEXPERT INFINITY
Yes: licensed in Canada
Licence status Issued (active); first licensed September 7, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89638
- Licence holder
- CepheidSunnyvale, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- September 7, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENEXPERT INFINITY-48S SYSTEM
- GENEXPERT INFINITY-80 SYSTEM
- GENEXPERT XPERT CHECK
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 “genexpert”. A notice may cover another product or only some lots: read it to see what it covers.
- GeneXpert Dx System - Xpert MRSA Assay (2017-11-28)February 1, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.