Enmed Microanalytics, Inc

EnMed MicroAnalytics, Inc. is a medical device company based in Charleston, SC that offers sample collection kits for COVID-19 testing. However, the company has received a warning letter from the United States Food and Drug Administration (FDA) for selling these products without proper marketing approval or authorization.

The FDA has determined that EnMed MicroAnalytics' sample collection kits are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, making them classified as medical devices. As a result, the company's products are considered adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. The FDA has urged EnMed MicroAnalytics to take immediate corrective action to prevent the sale of unapproved and unauthorized products for COVID-19.

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