ADVISORY TO ALL SUPPLIERS, DISTRIBUTORS OF COVID-19 RAPID ANTIGEN TEST KITS,* ANTIBODY TESTS (EQUIPMENT-BASED, ELISA/CLIA) AT STAGES 1 AND 2 OF APPLICATION FOR PRODUCT EVALUATION

All suppliers, distributors of COVID-19 Rapid Antigen Test Kits (non-self administered), Antibody tests (equipment-based, ELISA/CLIA) at stages 1 and 2 of their application for product evaluation are hereby advised to update their applications if they already have independent evaluations to facilitate the Institute’s recommendations to the Food and Drug Administration (FDA).
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