www.fdanews.com/articles/207277-biolytical-laboratories-istatis-covid-19-antigen-home-test-approved-in-canada
BioLytical Laboratories’ iStatis COVID-19 Antigen Home Test Approved in Canada
April 6, 2022
British Columbia, Canada-based bioLytical Laboratories has received Health Canada’s approval for its iStatis COVID-19 antigen home test.
The lateral flow immunoassay test, which can be performed at home, delivers easy-to-understand results, the company said.
Noting the scarcity of effective COVID-19 home tests, bioLytical Laboratories said it will manufacture the iStatis antigen tests in its ISO 13485 and Medical Device Single Audit Program-certified facility to deliver to customers “a reliable home test from a local manufacturer they can trust.”