FDAnews
www.fdanews.com/articles/132119-orasure-receives-fda-approval-for-final-phase-of-clinical-studies-for-hiv-test

OraSure Receives FDA Approval for Final Phase of Clinical Studies for HIV Test

November 22, 2010
OraSure Technologies Monday announced that the FDA has granted an investigational device exemption for the company to conduct the final phase of clinical testing for FDA approval of its OraQuick Rapid HIV-1/2 Antibody Test for sale in the consumer or over-the-counter market.
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