Status of active applications to the prequalification of in vitro diagnostics
This page provides an overview on the status of active applications submitted to the prequalification of in vitro diagnostics.
The information provided in the following tables gives an overview of the status for each product undergoing any of the three stages that form the prequalification assessment.
The indication “stage complete” for a product for any one of the stages does not imply it meets the acceptance criteria for that stage nor does it imply that the product has been prequalified.
The indication “R” means that information has been requested from the manufacturer and WHO is awaiting their reply and/or submission of additional documentation.
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HIV rapid tests
pdf, 48kb -
HIV/Syphilis tests
pdf, 43kb -
HIV EIA/other HIV tests
pdf, 50kb -
Hepatitis C tests
pdf, 50kb -
HBsAg tests
pdf, 48kb -
Malaria tests
pdf, 44kb -
CD4 technologies
pdf, 42kb -
HIV virological technologies
pdf, 46kb -
CD4 and Viral Load Technologies: Pre-submission Stage. PQDx process not started yet
pdf, 37kb