Medical device licence · 64093 · Class 3
LIFECODES HLA TYPING KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 31, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64093
- Licence holder
- Immucor Gti Diagnostics, Inc.Waukesha, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 31, 2004
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LIFECODES HLA-A ERES TYPING KIT
- LIFECODES HLA-B ERES TYPING KIT
- LIFECODES HLA-CERES
- LIFECODES HLA-DPA1/B1 SSO TYPING KIT
- LIFECODES HLA-DPB TYPING KIT
- LIFECODES HLA-DQA TYPING KIT
- LIFECODES HLA-DQA1/B1 SSO TYPING KIT
- LIFECODES HLA-DQB TYPING KIT
- LIFECODES HLA-DRB 3,4,5 TYPING KIT
- LIFECODES HLA-DRB1 ERES TYPING 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 “lifecodes”. A notice may cover another product or only some lots: read it to see what it covers.
- LIFECODES LSA Class IIJuly 2, 2026 · Haematology · Performance · Type II
- LIFECODES HLA-B SSO and HLA-B ERES SSO Typing Kit (2018-03-15)June 22, 2018 · Medical devices · Medical devices · Type III
- LIFECODES HLA-DRB1 SSO, HLA-DQA1/B1 SSO, and HLA-DPA/B1 SSO Typing Kit (2017-07-07)March 23, 2018 · Medical devices · Medical devices · Type III
- Lifecodes HLA-C eRES SSO Typing Kit (2016-05-02)May 16, 2016 · Medical devices · Medical devices · Type II
- LIFECODES HLA-DQA1/B1 Typing Kit (2015-12-22)January 14, 2016 · Medical devices · Health products · Type III
- LIFECODES LifeScreen Deluxe (LMX) (2015-10-13)October 13, 2015 · Medical devices · Health products · Type II
- Lifecodes PF4 IgG and Lifecodes PF4 IgG Enhanced (2014-12-10)January 9, 2015 · Medical devices · Medical devices · Type III
- Lifecodes HLA-DRB1 Typing Kit (2014-01-29)March 18, 2014 · Medical devices · Medical devices · Type III
- LifeCodes PF4 EnhancedSeptember 3, 2012 · Medical devices · Type III
- Lifecodes Platelet Antibody Screening KitSeptember 3, 2012 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.