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37 documents on 1 page
 
 
 
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A Guide to Aid the Selection of Diagnostic Tests. (Bull World Health Organ 2017;95:639–645)

Year:

2017;

Pages:

7;


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Harmonization of Rapid Diagnostic Tests for Malaria and Implications for Procurement. 26–27 February 2015 Geneva, Switzerland. Meeting Report

Year:

2015;

Pages:

45;


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Information for Manufacturers on the Inspection of Manufacturing Site(s). (Assessment of the Quality Management System) - WHO Prequalification of In Vitro Diagnostics

Year:

2017;

Pages:

32;


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Instructions for compilation of a product dossier - Prequalification of In Vitro Diagnostics Programme

Year:

2014;

Pages:

37;


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Instructions for the completion of the pre-submission form - Prequalification of In Vitro Diagnostics

Year:

2017;

Pages:

10;


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Malaria Rapid Diagnostic Test Performance: Results of Who Product Testing of Malaria Rdts: Round 7 (2015-2016). Geneva: World Health Organization; 2017

Year:

2017;

Pages:

164;


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Malaria Rapid Diagnostic Test Products: Suggested Use of Terms, Requirements and Preferences for Labelling and Instructions for Use. Geneva: World Health Organization; 2017

Year:

2017;

Pages:

39;


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Overview of the WHO Prequalification of in Vitro Diagnostics Assessment. Version 8. Geneva: World Health Organization; 2018 - WHO Prequalification of in Vitro Diagnostics

Year:

2018;

Pages:

28;


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Product dossier checklist - Prequalification of In Vitro Diagnostics Programme

Year:

2014;

Pages:

13;


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Technical Guidance Series 1 (TGS–1) for WHO Prequalification of in Vitro Diagnostic Medical Devices: Standards Applicable to the WHO Prequalification of in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

33;


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Technical Guidance Series 2 (Annex to TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing Component Stability of In Vitro Diagnostic Medical Devices

Year:

2019;

Pages:

24;


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Technical Guidance Series 2 (TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 5

Year:

2018;

Pages:

61;


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Technical Guidance Series 3 (TGS–3) for WHO Prequalification – Diagnostic Assessment: Principles of Performance Studies

Year:

2017;

Pages:

29;


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Technical Guidance Series 4 (TGS–4) for WHO Prequalification – Diagnostic Assessment: Guidance on Test Method Validation for in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

26;


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Technical Guidance Series 5 (TGS–5) for WHO Prequalification – Diagnostic Assessment: Designing Instructions for Use for in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

37;


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Technical Guidance Series 6 (TGS-6) for WHO Prequalification – Diagnostic Assessment: Panels for Quality Assurance and Quality Control of in Vitro Diagnostic Medical Devices

Year:

2017;

Pages:

57;


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Technical Guidance Series 7 (TGS-7) for WHO Prequalification - Diagnostic Assessment: Risk Management for Manufacturers of in Vitro Diagnostic Medical Devices

Year:

2018;

Pages:

66;


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Technical Guidance Series 8 (TGS-8) for WHO Prequalification – Diagnostic Assessment: Quality Control for In Vitro Diagnostic Medical Devices for WHO Prequalification. (Draft for Comment 9 April 2019)

Year:

2019;

Pages:

40;


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Technical Specifications Series 1 (TSS–1) for Submission to WHO Prequalification – Diagnostic Assessment: Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests for Professional Use And/Or Self-testing

Year:

2018;

Pages:

26;


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Technical Specifications Series 1 (TSS–1) for WHO Prequalification – Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 4

Year:

2018;

Pages:

34;


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Technical Specifications Series 2 (TSS–2) for Submission to WHO Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Activity

Year:

2016;

Pages:

22;


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Technical Specifications Series 3 (TSS–3) for Submission to WHO Prequalification – Diagnostic Assessment: Malaria Rapid Diagnostic Tests

Year:

2017;

Pages:

23;


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Technical Specifications Series 4 (TSS–4) for Submission to WHO Prequalification – Diagnostic Assessment: In Vitro Diagnostic Medical Devices (IVDs) Used for the Detection of High-risk Human Papillomavirus (HPV) Genotypes in Cervical Cancer Screening

Year:

2018;

Pages:

29;


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Technical Specifications Series 5 (TSS–5) for Submission to WHO Prequalification – Diagnostic Assessment: Rapid Diagnostic Tests (RDTs) Used for Surveillance and Detection of an Outbreak of Cholera

Year:

2018;

Pages:

25;


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Technical Specifications Series 6 (TSS–6) for Submission to WHO Prequalification – Diagnostic Assessment: Syphilis rapid diagnostic tests

Year:

2018;

Pages:

26;


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Technical Specifications Series 7 (TSS–7) for Submission to WHO Prequalification – Diagnostic Assessment: Rapid Diagnostic Tests to Detect Hepatitis C Antibody or Antigen. Geneva: World Health Organization; 2019

Year:

2019;

Pages:

33;


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Technical Specifications Series 8 (TSS–8) for Submission to WHO Prequalification – Diagnostic Assessment: Immunoassays to detect HCV antibody and/or antigen. Geneva: World Health Organization; 2019

Year:

2019;

Pages:

28;


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