Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240065571
Category : Medical
Languages : en
Pages : 43
Book Description
Instructions for compilation of a product dossier – IMDRF ToC. Prequalification of in vitro diagnostics
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240065571
Category : Medical
Languages : en
Pages : 43
Book Description
In vitro diagnostic medical devices used for the qualitative detection of SARS-CoV-2 nucleic acid
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240077758
Category : Medical
Languages : en
Pages : 34
Book Description
In vitro diagnostic medical devices for monitoring of blood glucose in capillary blood
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 924008293X
Category : Medical
Languages : en
Pages : 35
Book Description
Rapid diagnostic tests to detect mycobacterial lipoarabinomannan (LAM) antigen in urine
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240099794
Category : Medical
Languages : en
Pages : 33
Book Description
The 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 OrganizationPublisher: World Health Organization
ISBN: 9240077774
Category : Medical
Languages : en
Pages : 35
Book Description
In vitro diagnostic medical devices used for the quantitative detection of HIV-1 nucleic acid
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240057501
Category : Medical
Languages : en
Pages : 35
Book Description
In vitro diagnostic medical devices used for the qualitative and quantitative detection of Hepatitis C RNA
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 924005748X
Category : Medical
Languages : en
Pages : 34
Book Description
In vitro diagnostic medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240039341
Category : Medical
Languages : en
Pages : 31
Book Description
Immunoassays to detect hepatitis B virus surface antigen
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240063080
Category : Medical
Languages : en
Pages : 34
Book Description
Haemoglobin A1c point-of-care analysers for professional use
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240087613
Category : Medical
Languages : en
Pages : 32
Book Description