IVD Risk-based classification of diagnostics for WHO prequalification) (PQDx_172 v1, 13 May 2014) PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 1 - Standards applicable to the WHO Prequalification of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 2 - Establishing stability of in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Guidance Series (TGS) 4 - Test method validation for in vitro diagnostic medical devices Guideline/guidance
IVD Technical Guidance Series (TGS) 5 - Designing instructions for use for in vitro diagnostic medical devices PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 10 - In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA Guideline/guidance
IVD Technical Specifications Series (TSS) 11 - In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 13 - Rapid diagnostic tests to detect hepatitis B surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 14 - Immunoassays to detect hepatitis B virus surface antigen Guideline/guidance
IVD Technical Specifications Series (TSS) 15 - In vitro diagnostic medical devices used for the quantitative detection of Hepatitis B DNA Guideline/guidance
IVD Technical Specifications Series (TSS) 16 - Hepatitis C rapid diagnostic tests for professional use and/or self-testing, 2021 update Report
IVD Technical Specifications Series (TSS) 18 - Haemoglobin A1c point of care analysers for professional use PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 19 - In-vitro diagnostic medical devices for monitoring of blood glucose in capillary blood Guideline/guidance
IVD Technical Specifications Series (TSS) 20 - In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid Guideline/guidance
IVD Technical Specifications Series (TSS) 21 - SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing Guideline/guidance
IVD Technical Specifications Series (TSS) 24 - In Vitro diagnostic medical devices used for the qualitative detection of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis nucleic acid PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 25 - Rapid diagnotic tests to detect Neisseria gonorrhoeae antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 26 - Rapid diagnostic tests to detect Chlamydia trachomatis antigen PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 27 - Syphilis Rapid Diagnostic Tests for Professional Use and/or Self-testing PDF Guideline/guidance
IVD Technical Specifications Series (TSS) 9 - Immunoassays to detect HIV antibody and/or antigen PDF Guideline/guidance
IVD Template for public comments to draft TSS 22 – Haemoglobin point of care analysers. Submit comments to diagnostics@who.int by 17 June 2024 XLSX Guideline/guidance
IVD Template for public comments to draft TSS 3 – Malaria rapid diagnostic tests second edition. Submit comments to diagnostics@who.int by 17 June 2024 XLSX Guideline/guidance
IVD The Assessment Process for Listing of WHO Prequalification Evaluating Laboratories for IVDs PDF Guideline/guidance
IVD The assessment process for listing of WHO prequalification evaluating laboratories for IVDs (PQDx_248 v1.0, 23 May 2016) PDF Guideline/guidance
IVD Transitioning Emergency Use Listing for in vitro diagnostics to prequalification assessment - Questions and Answers PDF
IVD TSS 23 – Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine Guideline/guidance
IVD TSS 23– Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine, draft for comment. Comments to be submitted by 17 June 2024 PDF Guideline/guidance
IVD TSS 3 - Malaria rapid diagnostic tests second edition, draft for comment. Comments to be submitted by 17 June 2024 PDF Guideline/guidance
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: FilmArray Biothreat-E EUAL number: EAE 0433-154-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR Kit number: EAE 0432-139-00 PDF Report
IVD WHO EUAL Amended Public Report for Ebola IVD: Product: Liferiver™ ‒ Ebola Virus (EBOV) Real Time RT-PCR kit number: EAE 0432-139-00 PDF Report