OraSure Technologies OraQuick
This article was originally published in The Gray Sheet
Executive Summary
Firm files premarket approval application for the rapid HIV test, designed to detect antibodies within 20 minutes in oral fluid, whole blood, serum or plasma (1"The Gray Sheet" May 1, 2000, p. 17). The PMA covers serum and whole blood only. OraSure expects to file for use with oral fluid in the fourth quarter, upon completion of related trials