Medical device licence · 79366 · Class 3
ALLSET GOLD SSP
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79366
- Licence holder
- One Lambda IncWest Hills, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- March 24, 2009
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALLSET GOLD ABC LOW RESOLUTION KIT
- ALLSET GOLD ABDR LOW RESOLUTION KIT
- ALLSET GOLD ABDRQ LOW RESOLUTION KIT
- ALLSET GOLD DQB CLASS II HIGH RESOLUTION KITS
- ALLSET GOLD DR LOW RESOLUTION KIT
- ALLSET GOLD DRB CLASS II HIGH RESOLUTION KITS
- ALLSET GOLD DRDQ LOW RESOLUTION KIT
- ALLSET GOLD HLA LOW RESOLUTION KITS
- ALLSET GOLD SSP HLA CLASS I HIGH RESOLUTION KITS
- ALLSET GOLD SSP HLA DIRECT TO HIGH RESOLUTION KITS
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 “allset”. A notice may cover another product or only some lots: read it to see what it covers.
- Allset+ Gold Locus High Resolution Kits (2017-06-27)July 17, 2017 · Medical devices · Medical devices · Type II
- AllSet Gold SSP (2016-05-06)July 29, 2016 · Medical devices · Medical devices · Type III
- ALLSET GOLD HIGH RES SSP UNITRAY (2015-07-08)August 18, 2015 · Medical devices · Health products · Type III
- ALLSET GOLD SSP (2015-04-15)May 8, 2015 · Medical devices · Health products · Type III
- ALLSET Gold DRB Class II High Resolution Kits and SSP Unitray (2015-02-09)March 5, 2015 · Medical devices · Health products · Type III
- Allset Gold DPB1 High Resolution SSP Kit, DPB1 SSP UniTray 12 Tests and DPB1 SSP UniTray With Taq 12 Tests (2014-08-14)September 16, 2014 · Medical devices · Medical devices · Type II
- Allset+T Gold HLA ABC Low Resolution (2014-03-11)April 4, 2014 · Medical devices · Medical devices · Type III
- Allset Gold SSP HLA Direct to High Resolution Kit and SSP Unitray - High Resuloution Class II (2013-07-10)March 25, 2014 · Medical devices · Medical devices · Type III
- Allset Gold DPB1 High Resolution SSP and DPB1 SSP Unitray 12 Tests, DPB1 SSP Unitray with Taq 12 Test (2013-12-30)March 25, 2014 · Medical devices · Medical devices · Type III
- Allset Gold and SSP Unitray low resolution kits (2013-10-22)March 20, 2014 · Medical devices · Medical devices · Type III
- Allset Gold and SSP Unitary Low Resolution Kits (2013-08-30)November 29, 2013 · Medical devices · Medical devices · Type III
- AllSet Gold SSP HLA-DRB1 High Res. Kit and DRB1 SSP UniTray KitJune 11, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.