Medical device licence · 63502 · Class 2
UREA
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 14, 2004; ended October 28, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63502
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 14, 2004
- Ended
- October 28, 2022
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UREA (MODIFIED UREASE-BERTHELOT METHOD MANUAL)
- UREA (UREASE-BERTHELOT METHOD COLORIMETRIC MANUAL)
- UREA ASSAY FOR DIMENSION
- UREA ASSAY FOR HITACHI 704, 717, 902, 911/912
- UREA ASSAY FOR HITACHI 917 - HITACHI MODULAR P
- UREA ASSAY FOR HITACHI 917, 911/912
- UREA ASSAY FOR SYNCHRON CX 4/5/7 & LX 20
- UREA ASSAY MANUAL METHOD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.