Chembio diagnostics, inc. receives who prequalification approval for hiv self-test

November 4, 2019 chembio diagnostics, inc. announced its sure check hiv self-test has received world health organization prequalification approval. the who prequalification of in vitro diagnostics (ivd) is a comprehensive assessment of individual ivds through a standardized process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review. it signifies that the product meets global standards of quality, safety and performance, and is used by united nations and other procurement agencies such as pepfar, unitaid, and the global fund to make purchasing decisions.
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