Instructions for compilation of a product dossier – IMDRF ToC. Prequalification of in vitro diagnostics
Author: World Health Organization
Publisher: World Health Organization
Published: 2024-01-22
Total Pages: 43
ISBN-13: 9240065571
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In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-10-02
Total Pages: 34
ISBN-13: 9240077758
DOWNLOAD EBOOKIn vitro diagnostic medical devices for monitoring of blood glucose in capillary blood
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-11-23
Total Pages: 35
ISBN-13: 924008293X
DOWNLOAD EBOOKRapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine
Author: World Health Organization
Publisher: World Health Organization
Published: 2024-10-22
Total Pages: 33
ISBN-13: 9240099794
DOWNLOAD EBOOKThe document is developed for manufacturers who are interested in applying for WHO prequalification assessment, to assist in the compilation of their product dossier. The document summarizes the minimum analytical and clinical performance studies to be conducted for rapid diagnostic tests (RDTs) for the qualitative detection of mycobacterial lipoarabinomannan (LAM) antigen for point of care professional use in urine of HIV positive individuals.
SARS-CoV-2 antigen rapid diagnostic tests for professional use and self-testing
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-10-02
Total Pages: 35
ISBN-13: 9240077774
DOWNLOAD EBOOKIn vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-03-06
Total Pages: 35
ISBN-13: 9240057501
DOWNLOAD EBOOKIn vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-03-06
Total Pages: 34
ISBN-13: 924005748X
DOWNLOAD EBOOKIn vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid
Author: World Health Organization
Publisher: World Health Organization
Published: 2021-11-30
Total Pages: 31
ISBN-13: 9240039341
DOWNLOAD EBOOKImmunoassays to detect hepatitis B virus surface antigen
Author: World Health Organization
Publisher: World Health Organization
Published: 2023-03-16
Total Pages: 34
ISBN-13: 9240063080
DOWNLOAD EBOOKHaemoglobin A1c point-of-care analysers for professional use
Author: World Health Organization
Publisher: World Health Organization
Published: 2024-01-29
Total Pages: 32
ISBN-13: 9240087613
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