Medical device licence · 61220 · Class 3
LABTYPE SSO DNA TYPING TESTS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 16, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 61220
- Licence holder
- One Lambda IncWest Hills, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- December 16, 2002
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LABTYPE HD A LOCUS TYPING TEST
- LABTYPE HD B LOCUS TYPING TEST
- LABTYPE HD C LOCUS TYPING TEST
- LABTYPE SSO B7 SUPPLEMENT TYPING TEST
- LABTYPE SSO CLASS I A LOCUS TYPING TEST
- LABTYPE SSO CLASS I B LOCUS TYPING TEST
- LABTYPE SSO CLASS I C LOCUS TYPING TEST
- LABTYPE SSO CLASS I EXON 4-7 SUPPLEMENTAL DNA TYPING TESTS
- LABTYPE SSO CLASS II DPA1/DPB1 TYPING TEST
- LABTYPE SSO DQA1/DQB1 TYPING TEST
- LABTYPE SSO DRB1 TYPING TEST
- LABTYPE SSO DRB3,4,5 TYPING TEST
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 “labtype”. A notice may cover another product or only some lots: read it to see what it covers.
- LABType Typing Tests (2016-09-29)November 9, 2016 · Medical devices · Medical devices · Type II
- LABType HD DRB1 Typing Test(2015-08-26)September 24, 2015 · Health products · Health products · Type II
- LABType HD DRB1 Typing TestMarch 6, 2015 · Medical devices · Type II
- LABType HD Class II DRB1 Typing TestNovember 26, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.