Medical device licence · 111698 · Class 2
CYSTATIN C (CYSC)
Yes: licensed in Canada
Licence status Issued (active); first licensed August 16, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111698
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- August 16, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CYSTATIN C (CYSC)
- CYSTATIN C CALIBRATOR (CYSC CAL)
- CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2)
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.