Descripción general de la Precalificación de Diagnósticos in vitro de la OMS pdf
Directives pour la préparation d'un dossier d'information par le laboratoire (2011) pdf
Disclaimer for WHO list of prequalified diagnostic products pdf
DRAFT TSS 10 In vitro diagnostic (IVD) medical devices used for the qualitative and quantitative detection of hepatitis C RNA — to be published shortly — draft document pdf
DRAFT TSS 11 In vitro diagnostic (IVD) medical devices used for the quantitative detection of HIV-1 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 12 In vitro diagnostic (IVD) medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid — to be published shortly — draft document pdf
DRAFT TSS 13 Rapid diagnostic tests to detect hepatitis B surface antigen — to be published shortly pdf
DRAFT TSS 14 Immunoassays to detect hepatitis B virus surface antigen — to be published shortly pdf
DRAFT TSS 15 In vitro diagnostic (IVD) medical devices used for the quantitative detection of hepatitis B nucleic acid — to be published pdf
DRAFT TSS 9 Immunoassays to detect HIV antibody and/or antigen — to be published shortly pdf
Draft: Instructions for compilation of a product dossier ‒ IMDRF ToC (PQDx_018, 21 March 2020) pdf
