Medical device licence · 68357 · Class 2
LEUKOSURE ENUMERATION KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed May 10, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68357
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- May 10, 2005
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEUKOSURE ENUMERATION 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 “leukosure”. A notice may cover another product or only some lots: read it to see what it covers.
- Leukosure Enumeration KitDecember 15, 2022 · Haematology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.