Description

The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics.

Resources

Name	Format	Description	Link
Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/covid19-requirements-serological-antibody-tests.html
Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/covid19-exigences-relatives-tests-serologiques-anticorps.html

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