Chembio diagnostics receives who prequalification approval for malaysia facility

Chembio diagnostics, inc. announced its manufacturing facility in malaysia has been qualified by the world health organization (who) prequalification program to produce stat-pak hiv 1/2 tests. the who prequalification of in vitro diagnostics (ivd) is a comprehensive assessment of individual ivds through a standardized assessment process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review.
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