In Vitro Diagnostics Under Assessment

Information provided here consists of an overview of the evaluation status of each in vitro diagnostic or male circumcision device currently undergoing evaluation for prequalification. For each product the status for each stage of evaluation is given. 

The indication “stage complete” for any one of the stages does not imply that the product concerned meets the acceptance criteria for that stage, nor should it be taken to imply that the product has been prequalified. 

The indication “R” means that information has been requested from the manufacturer and that the WHO is awaiting a reply and/or submission of additional documentation.