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WHO list of prequalified in vitro diagnostic products

World Health Organization (2017) C_WHO
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: GeeniusTM HIV 1/2 Confirmatory Assay with GeeniusTM HIV 1/2 Confirmatory Controls, WHO reference number: PQDx 0181-031-00)

World Health Organization (2017) C_WHO
PQDx 0181-031-00 WHO PQ Public Report March/2017, version 3.0
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Malaria Rapid Diagnostic Test Performance. Summary results of WHO product testing of malaria RDTs: round 1 -7 (2008 –2016)

E. Heseltine World Health Organisation (WHO) (2017) C_WHO
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WHO Prequalification of Diagnostics Programme -Public Report (Product: BD FACSPrestoTM Near-Patient CD4 Counter System, PQ number: PQDx 0197-045-00)

World Health Organization (2016) C_WHO
PQDx 0197-045-00 WHO PQDx PR March /2016, version 2.0
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Regional Strategy on Regulation of Medical Products in the African Region, 2016–2025

World Health Organization, Regional Office for Africa (2016) C_WHO
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof... more
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WHO Prequalification of Male Circumcision Devices - Product: PrePex, Number: PQMC 0001-001-04

World Health Organization (WHO) World Health Organization (WHO) (2016) C_WHO
Public Report PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
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WHO Prequalification of Diagnostics Programme - Public Report (Product: ABONtm HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device, Number: PQDx 0141-051-00)

World Health Organization (2017) C_WHO
PQDx 0141-051-00 WHO PQDx Public Report April/2017, version 5.0
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: OraQuick HIV 1/2 Rapid Antibody Test, WHO reference number: PQDx 0159-055-00)

World Health Organization (2017) C_WHO
PQDx 0159-055-00 WHO PQ Public Report February/2017, version 5.0
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WHO Prequalification of Diagnostics Programme - Public Report (Product: Alere DetermineTM HIV-1/2, Number: PQDx 0033-013-00)

World Health Organization (2016) C_WHO
PQDx 0033-013-00 WHO PQ Public Report July/2016, version 5.0
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: DPP® HIV 1/2 Assay, WHO reference number: PQDx 0053-006-00)

World Health Organization (2016) C_WHO
PQDx 0053-006-00 WHO PQ Public Report June/2016, version 2.0
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WHO Prequalification of Diagnostics Programme - Public Report (Product: Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device), Number: PQDx 0005-005-00)

World Health Organization (2016) C_WHO
PQDx 0005-005-00 WHO PQDx PR May/2016, version 3.0
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WHO Prequalification of Male Circumcision Devices - Product: ShangRingTM, Number: PQMC 0003-003-00

World Health Organization (WHO) World Health Organization (WHO) (2015) C_WHO
Public Report PQMC 0003-003-00 WHO PQMC PR June/2015, version 2.0
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WHO Global Surveillance and Monitoring System for substandard and falsified medical products

World Health Organization WHO (2017) C_WHO
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WHO report on the global tobacco epidemic, 2021: addressing new and emerging products

World Health Organization WHO (2021) C_WHO
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Rwanda: GUIDELINES ON VARIATIONS TO A REGISTERED PHARMACEUTICAL PRODUCT

Ministry of Health, Rwanda (2015) C2
Rwanda Guidelines for variation to registered pharmaceutical products.
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Enzygnost HIV Integral 4, WHO reference number: PQDx 0214-064-00

World Health Organization (2016) C_WHO
PQDx 0214-064-00 WHO PQDx PR April/2016, version 3.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: MP Diagnostics HIV Blot 2.2, Number: PQDx 0198-071-00)

World Health Organization (2016) C_WHO
PQDx 0198-071-00 WHO PQDx PR April/2016, version 2.0
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Botswana: Guidelines for stability testing of pharmaceutical products

Ministry of Health, Gabarone, Botswana (2009) C2
This guideline is intended to provide requirements to applicants wishing to submit applications for registration of medicines in Botswana.
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AlereTM HIV/Syphilis Duo, Number: PQDx 0179-012-00)

World Health Organization (2017) C_WHO
PQDx 0179-012-00 WHO PQDx Public Report June/2017, version 4.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: SD BIOLINE HIV-1/2 3.0, Number: PQDx 0027-012-00)

World Health Organization (2017) C_WHO
PQDx 0027-012-00 WHO PQDx Public Report May/2017, version 4.0