Medical device licence · 103458 · Class 2
ANTI-TSHR
Yes: licensed in Canada
Licence status Issued (active); first licensed August 16, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103458
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 16, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALSET ANTI-TSHR
- ELECSYS ANTI-TSHR
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 “anti-tshr”. A notice may cover another product or only some lots: read it to see what it covers.
- Elecsys® Anti-TSHRDecember 23, 2025 · Chemistry · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.