Medical device licence · 95764 · Class 3
OLERUP SBT HARPS
No longer licensed: cancelled
Licence status Cancelled; first licensed September 15, 2015; ended June 28, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 95764
- Licence holder
- Caredx AbFremantle, WA, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 15, 2015
- Ended
- June 28, 2022
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASSIGN SBT V4.7 SEQUENCE ANALYSIS SOFTWARE
- OLERUP ASSIGN SBT V471 SEQUENCE ANALYSIS SOFTWARE
- OLERUP SBT HARPS C1
- OLERUP SBT HARPS PB
- OLERUP SBT HARPS QB
- OLERUP SBT HARPS RB
- SBT RESOLVER HARPS C1
- SBT RESOLVER HARPS PB
- SBT RESOLVER HARPS QB
- SBT RESOLVER HARPS RB
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 “olerup”. A notice may cover another product or only some lots: read it to see what it covers.
- OLERUP SSP HLA-A (2016-05-04)May 24, 2016 · 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.