Health Canada
Lucira Health SARS-CoV-2 Self-Test Receives Health Canada Conditional Authorization
The molecular test kit will be available for Canadians to order online by June and will cost around C$75.
GenDx HLA Genotyping Products Receives Health Canada IVD Approval
The products combine next-generation sequencing and analysis with the company's NGSengine software to provide high-resolution HLA genotyping information.
OraSure Saliva Collection Device Gets Canada Authorization for COVID-19 Testing
The device also has Emergency Use Authorization from the US Food and Drug Administration and has CE marking for in vitro diagnostic use.
Quidel SARS-CoV-2 Test Receives Expanded FDA Emergency Use Authorization
Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.
SpeeDx Gets Health Canada Approval for Mycoplasma Genitalium ID, Drug Resistance Test
The test could potentially enable labs to bring resistance testing in house, rather than send testing out to Canada's National Microbiology Laboratory.
Nov 13, 2018
Health Canada Approves Two BCR-ABL Tests
Jun 21, 2017
3M Listeria Assay Approved by Health Canada
Mar 14, 2017
Roche EGFR Mutation Test Approved in Canada
Oct 10, 2014
GenDx Gets Canadian ISO Certification
May 7, 2014
NanoString Gets Canadian OK for Prosigna Assay
Feb 24, 2014