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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

Sample product dossier for a qualitative nucleic acid‑based testing technology for HIV-1 and HIV-2

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO risk based approach for the assessment of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO technical guidance series 2 - establishing stability of IVDs ANNEX

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO technical guidance series 7 - risk management for manufacturers of IVDs

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO prequalification performance evaluation protocols

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

WHO overview of prequalification of IVDs assessment

Author : WHO

Topic : WHO Prequalification

Type of document : Guidelines

Document Category : Guidance for manufacturers

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