Medical device licence · 72426 · Class 2
ALDOLASE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72426
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- September 29, 2006
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALDOLASE MANUAL METHOD
- ALS CAL
- ALS CONTROL
- ALS CONTROL 3
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 “aldolase”. A notice may cover another product or only some lots: read it to see what it covers.
- ALDOLASE MANUAL METHOD (2016-05-30)June 13, 2016 · 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.