Medical device licence · 69506 · Class 2
VISULIZE FACTOR VIII ANTIGEN KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 17, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69506
- Licence holder
- Affinity Biologicals Inc.Ancaster, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 17, 2005
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VISULIZE FACTOR VIII ANTIGEN KIT
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 “visulize”. A notice may cover another product or only some lots: read it to see what it covers.
- VisuLize Factor VIII Antigen Kit (2018-02-13)February 22, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.