Resources

HIV Early Infant Diagnosis and Viral Load POC Diagnostics: Market and Supply Update, March 2020

Author : UNICEF

Topic : Procurement

Document Category : Guidance for manufacturers

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WHO technical guidance series 1 - standards applicable to WHO Prequalification of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO technical guidance series 5 - designing instructions for use for IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

Sample product dossier for CD4 enumeration technology

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

Technical Specification Series to WHO Prequalification - Diagnostics Assessment: HIV rapid diagnostic tests for professional use and/or self-testing

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO technical guidance series 4 - test method validation for IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

Sample product dossier for a quantitative nucleic acid-based testing technology to measure HIV-1 RNA

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO risk based classification of diagnostics for WHO prequalification

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO technical guidance series 3 - principles of performance studies

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

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