Medical device licence · 90080 · Class 3
IMMUNOASSAY PREMIUM PLUS CONTROLS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 9, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90080
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 9, 2012
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMMUNOASSAY CONTROL PREMIUM PLUS LEVEL 1
- IMMUNOASSAY CONTROL PREMIUM PLUS LEVEL 2
- IMMUNOASSAY CONTROL PREMIUM PLUS LEVEL 3
- IMMUNOASSAY CONTROL PREMIUM PLUS TRI-LEVEL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.