Medical device licence · 63483 · Class 2
DIRECT BILIRUBIN
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 9, 2004; ended October 25, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63483
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- January 9, 2004
- Ended
- October 25, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECT BILIRUBIN - MANUAL METHODS
- DIRECT BILIRUBIN ASSAY FOR DADE DIMENSION
- DIRECT BILIRUBIN ASSAY FOR HITACHI 704, 705, 717, 902, 911/912
- DIRECT BILIRUBIN ASSAY FOR HITACHI 917
- DIRECT BILIRUBIN ASSAY FOR SYNCHRON CX 4/5/7/9 - SYNCHRON LX 20
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.