Medical device licence · 103101 · Class 2
ANTI-KAPPA
Yes: licensed in Canada
Licence status Issued (active); first licensed June 28, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103101
- Licence holder
- Immunotech S.A.S., A Beckman Coulter CompanyMarseille Cedex 09, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 28, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTI-KAPPA-APC (GOAT POLYCLONAL)
- ANTI-KAPPA-FITC
- ANTI-KAPPA-FITC (GOAT POLYCLONAL)
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 “anti-kappa”. A notice may cover another product or only some lots: read it to see what it covers.
- Bd Anti-Kappa PeMay 3, 2022 · Haematology · Manufacturing defect · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.