Device for Coonan’s HIV Test Kit Gets FDA Approval
COSTA MESA —
Coonan Clinical Laboratories Inc. said Tuesday that the U.S. Food and Drug Administration has approved its blood sampling device for use in its proposed in-home test for HIV.
This approval permits the Costa Mesa company to submit the final application for the remainder of the test kit, called HIV-1 Home Check.
The kit, which would be available over the counter or through the mail if it is approved, would allow purchasers to collect a dried blood sample at home. A laboratory analysis of the sample would be performed anonymously by mail.
