Medical device licence · 99614 · Class 3
AFINION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99614
- Licence holder
- Abbott Diagnostic Technologies AsOslo, 03, Norway
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 8, 2017
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AFINION 2
- AFINION CRP
- AFINION CRP CONTROL
- AFINION HBA1C
- AFINION HBA1C CONTROL
- AFINION LIPID PANEL
- AFINION LIPID PANEL CONTROL
- ALERE AFINION CRP
- ALERE AFINION CRP CONTROL
- ALERE AFINION HBA1C
- ALERE AFINION HBA1C CONTROL
- ALERE AFINION LIPID PANEL
- ALERE AFINION LIPID PANEL CONTROL
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 “afinion”. A notice may cover another product or only some lots: read it to see what it covers.
- Alere Afinion AS100 Analyzer & Alfinion 2 (2020-03-22)April 17, 2020 · 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.