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Product Streams
Immunization Devices
Menu Column 1
About Immunization Devices Prequalification
What We Do
Documents A-Z
WHO Catalogue of Prequalified Immunization Devices
Menu Column 2
Procuring Prequalified Products
Standards Overview
Prequalification Procedures & Fees
Evaluation process
Retroactivity and grandfathering
Product Testing Support for Manufacturers
Laboratory Accreditation for Product Testing
Menu Column 3
Post-prequalification Procedures & Fees
Post-market Monitoring
Enhancing post-market monitoring
Guidance Documents
Prequalification guidance for manufacturers
Performance specifications
Verification protocols
Target product profiles
Standard operating procedures
Supporting information for users
Market Information
In Vitro Diagnostics
Menu Column 1
About In Vitro Diagnostic & Male Circumcision Device Prequalification
What We Do
Documents A-Z
Prequalified In Vitro Diagnostics
Prequalified Male Circumcision Devices
In Vitro Diagnostics Under Assessment
Menu Column 2
IVDs Eligible for WHO Prequalification
MCDs Eligible for Prequalification
MCDs Under Assessment
Prequalification Procedures & Fees: IVDs
Prequalification Procedures & Fees: MCDs
Post-prequalification Procedures & Fees: Prequalified IVDs
Annual reporting
Changes to prequalified IVDs
Post-market surveillance
Post-prequalification Procedures: Prequalified MCDs
Menu Column 3
Prequalification Reports
WHO Public Reports
WHO Public Inspection Reports
Collaborative Procedure for Accelerated Registration
Guidance Documents
Prequalification guidance
Technical Specifications Series
Technical Guidance Series
Sample product dossiers
Support to Manufacturers
Technical advice
Pre-submission meetings
Specialized technical assistance
Emergency Use Listing Procedure
Expert Review Panel for Diagnostics
Market Information
Medicines
Menu Column 1
About Medicines Prequalification
What We Do
Documents A-Z
Prequalification Pipeline
FPPs under assessment
Prequalified Lists
Finished pharmaceutical products
Active pharmaceutical ingredients
Medicines quality control laboratories
FPPs and APIs Eligible for Prequalification ("EOIs")
Menu Column 2
Prequalification Procedures & Fees: FPPs, APIs & QCLs
Medicines / FPPs
Active pharmaceutical ingredients
Medicines quality control laboratories
Post-prequalification Procedures & Fees: APIs, FPPs, QCLs
Amendments to APIMFs
Variations to FPPs
Requalification of FPPs
Quality monitoring
Monitoring QCL performance
Prequalification Reports
WHO Public Assessment Reports
WHO Public Inspection Reports
Collaborative Procedures for Accelerated Registration
Accelerated registration of prequalified FPPs
Accelerated registration of FPPs approved by SRAs
Menu Column 3
Guidance Documents
WHO Technical Report Series
WHO medicines prequalification guidance
International Pharmacopoeia
Pilot Prequalification of Biotherapeutic Products
Support to Manufacturers, CROs and QCLs
Technical advice
Pre-submission meetings
Specialized technical assistance
Capacity building for QCLs
Risk Assessment
Market Information
Vaccines
Menu Column 1
About Vaccines Prequalification
What We Do
Documents A-Z
List of Prequalified Vaccines
Prequalified vaccines
Menu Column 2
Vaccines Eligible for WHO Prequalification
Prequalification Procedures & Fees
Assessment
Fees for prequalification
Post-prequalification Procedures
Variation classification
Prequalified vaccine annual report (PQVAR)
Reassessment
Targeted testing
Complaints handling by WHO
Menu Column 3
Guidance Documents
WHO Technical Report Series
WHO position papers
SAGE reports
Biological reference preparations
Vaccine information by disease category
Prequalification Reports
WHO Public Assessment Reports
WHO Public Inspection Reports
Emergency Use Listing Procedure
Market Information
Risk Assessment - Snake Antivenom
Snake antivenom assessment procedure
Call for Applications
List of Product Assessment Outcomes
TAG-SAIL
Guidelines
Vector Control Products
Menu Column 1
About Vector Control Products Prequalification
What We Do
Documents A-Z
Menu Column 2
List of Prequalified Vector Control Products
Prequalification Pipeline
Prequalification Procedures & Fees
Determination of pathway
Pre-submission
Dossier preparation
Submitting applications
Screening & assessment
Post-prequalification Procedures & Fees
Menu Column 3
Prequalification Reports
WHO Public Inspection Reports
ITN Product Review Report
WHO Specifications for Pesticides
Guidance Documents
Inspection Services
Menu Column 1
About Inspection Services
What We Do
Menu Column 2
Documents A-Z
Inspection Services Procedures
WHO Public Inspection Reports (WHOPIRs)
Menu Column 3
Notice of Concern
International Collaboration
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WHO Public Reports for In Vitro Diagnostics
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CD4 assays
Hepatitis B assays
Hepatitis C assays
HIV Nucleic Acid Tests
HIV Self-Test
HIV serology
HIV/Syphilis Combo Assays
HPV virological technologies
Malaria rapid diagnostics tests
Syphilis rapid diagnostic tests
Apply
Hepatitis C assays
Public Report for Abbott RealTime HCV, (PQDx 0450-027-00)
Public Report for Alinity m HCV, (PQDx 0461-027-00)
Public Report for ARCHITECT HCV Ag assay, (PQDx 0374-130-00)
Public Report for Bioline HCV (PQDx 0257-012-00)
Public Report for cobas HCV (Quantitative nucleic acid test for use on the cobas 6800/8800 Systems) (PQDx 0465-118-00)
HPV virological technologies
Public report for Abbott RealTime High Risk HPV (PQDx 0455-180-00)
Public report for careHPV Test (PQDx 0085-028-00)
Public report for cobas HPV (PQDx 0468-046-00)
HIV Nucleic Acid Tests
Public report for Abbott RealTime HIV-1 (m2000sp) (PQDx 0145-027-00)
Public report for Abbott RealTime HIV-1 (m24sp) (PQDx 0083-027-00)
Public report for Abbott RealTime HIV-1 (Manual) (PQDx 0146-027-00)
Public report for Abbott RealTime HIV-1 Qualitative (m2000sp), (PQDx 0084-027-00)
Public report for Abbott RealTime HIV-1 Qualitative (Manual), (PQDx 0151-027-00)
Public report for Aptima HIV-1 Quant Dx Assay (PQDx 0236-078-00)
Public Report for cobas HIV-1 Nucleic acid test for use on the cobas 4800 system (PQDx 0710-118-00)
Public Report for cobas HIV-1 Quantitative nucleic acid test for use on the cobas 4800 System (PQDx 0373-118-00)
Public report for cobas HIV-1 Quantitative nucleic acid test for use on the cobas 6800/8800 Systems (PQDx 0365-118-00)
Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 (TaqMan 48) (PQDx 0221-046-00)
Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0 (TaqMan 96) (PQDx 0200-046-00)
Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 48) (PQDx 0126-046-00)
Public report for COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0 (TaqMan 96) (PQDx 0147-046-00)
HIV serology
Public report for ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (PQDx 0141-051-00)
Public Report for AiD anti-HIV 1+2 ELISA, (PQDx 0006-005-00)
Public Report for Bioline HIV 1/2 3.0 (PQDx 0027-012-00)
Public Report for Determine HIV Early Detect (PQDx 0243-013-00)
Public Report for Determine HIV-1/2 (PQDx 0033-013-00)
Public Report for Diagnostic Kit for HIV(1+2) Antibody (Colloidal Gold) V2, (PQDx 0267-037-00)
Public report for DPP® HIV 1/2 Assay (PQDx 0053-006-00)
Public Report for DS-EIA-HIV-AGAB-SCREEN, (PQDx 0106-038-00)
Malaria rapid diagnostics tests
Public Report for AdvDx Malaria Pf Rapid Malaria Ag Detection Test, (PQDx 0345-101-00)
Public Report for Bioline Malaria Ag P.f (HRP2/pLDH) (PQDx 0209-012-00)
Public Report for Bioline Malaria Ag P.f (PQDx 0031-012-01)
Public Report for Bioline Malaria Ag P.f/P.f/P.v (PQDx 0297-012-00)
Public Report for Bioline Malaria Ag P.f/P.v (PQDx 0125-012-00)
Public Report for Bioline Malaria Ag P.f/Pan (PQDx 0030-012-01)
Public Report for CareStart™ Malaria HRP2 (Pf), (PQDx 0137-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf), (PQDx 0188-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO, (PQDx 0136-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO, (PQDx 0138-049-00)
Public Report for CareStart™ Malaria pLDH (PAN), (PQDx 0234-049-00)
CD4 assays
Public Report for Aquios CL flow cytometer, (PQDx 0156-053-00)
Public report for BD FACSCountTM Instrument System with FACSCountTM Control Kit and BD FACSCountTM CD4 Reagent Kit (Absolute and Percentage CD4+ Counts), (PQDx 0133-045-00)
Public report for BD FACSCount™ Instrument System with FACSCount™ Control Kit and BD FACSCount™ Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts), (PQDx 0124-045-00)
Public report for BD FACSPresto™ Near-Patient CD4 Counter with BD CD4%CD4/Hb Cartridge and BD FACSPresto™ Cartridges Kit, (PQDx 0197-045-00)
Public Report for CyFlow Counter System with CD4 easy count kit and CD4% easy count kit, (PQDx 0350-081-00)
Hepatitis B assays
Public Report for Bioline HBsAg WB (PQDx 0219-012-00)
Public Report for Determine HBsAg 2 (PQDx 0451-013-00)
HIV/Syphilis Combo Assays
Public Report for Bioline HIV/Syphilis Duo, (PQDx 0179-012-00)
HIV Self-Test
Public Report for CheckNOW HIV SELF TEST (PQDx 0481-032-00)
Syphilis rapid diagnostic tests
Public Report for Determine Syphilis TP (PQDx 0485-013-00)
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