FDA says OraSure's OraQuick HIV test "approvable":
This article was originally published in Clinica
OraSure Technologies' OraQuick HIV-1 blood test has moved a step closer to the US market, after the FDA decided that it was "approvable". The finger stick test, which is intended to detect HIV-1 antibodies in whole blood within 20 minutes, is planned for launch in the second half of 2002, said the Bethlehem, Pennsylvania company. Final FDA product approval, however, is subject to the company submitting product labelling and resolving specific validation and design control issues.
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