EnMed Marketing Unapproved Covid Sample Kit: FDA

FDA says its review of a Web site maintained by EnMed MicroAnalytics, Charleston, SC, determined that the firm offers Covid-19 blood sample collection kits that are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19 in people and thus are legally medical devices. A 1/25 Warning Letter says the kits are offered for sale and distributed in the U.S. without FDA marketing approval, clearance, or authorization, and thus the products are adulterated.

EnMed was told to take prompt action to address the violations cited in the letter and to respond with a list of specific steps taken to address the violations and prevent their recurrence, with related documentation.

FDA says the firm will be added to its list of Web sites that have received Warning Letters concerning the sale or distribution of Covid-19 related products in violation of the Federal Food, Drug, and Cosmetic Act.