Medical device licence · 76097 · Class 4
GENEXPERT DX SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 24, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76097
- Licence holder
- CepheidSunnyvale, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- January 24, 2008
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENEXPERT DX SYSTEM - INSTRUMENT (MODULE VARIATIONS)
- 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.