Medical device licence · 67643 · Class 2
HAEMOGLOBIN A1C
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 3, 2005; ended October 25, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 67643
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 3, 2005
- Ended
- October 25, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HAEMOGLOBIN A1C IMMUNOTURBIDIMETRIC METHOD
- HAEMOGLOBIN A1C L.E.I. METHOD
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 “haemoglobin”. A notice may cover another product or only some lots: read it to see what it covers.
- D-10 HAEMOGLOBIN TESTING SYSTEM - HBA1C KIT (2016-01-07)January 25, 2016 · Medical devices · Medical devices · Type II
- D-10 Haemoglobin Testing System - Analyzer (2014-03-14)April 22, 2014 · Medical devices · Medical devices · Type II
- D-10 Haemoglobin Testing System - Dual Program (HBA2/E/AIC) (2013-12-19)January 17, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.