Medical device licence · 100522 · Class 3
IDYLLA KRAS MUTATION TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100522
- Licence holder
- Biocartis NvMechelen, Belgium
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- February 6, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IDYLLA KRAS MUTATION TEST
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 “idylla”. A notice may cover another product or only some lots: read it to see what it covers.
- Idylla InstrumentDecember 30, 2024 · Chemistry · Performance · Type II
- Idylla™ EGFR mutation testJune 14, 2024 · Haematology · Performance · Type II
- Idylla EGFR Mutation Test (2020-02-22)March 13, 2020 · 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.