Medical device licence · 82276 · Class 3
OLERUP SSP HLA NEGATIVE CONTROL
Yes: licensed in Canada
Licence status Issued (active); first licensed March 15, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82276
- Licence holder
- Caredx AbFremantle, WA, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 15, 2010
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OLERUP SSP HLA NEGATIVE CONTROL INCLUDING TAQ POLYMERASE
- OLERUP SSP HLA NEGATIVE CONTROL WITHOUT TAQ POLYMERASE
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
- Olerup SSP - SSP Combi Trays (2014-05-29)July 15, 2014 · 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.