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Diagnosis
FDA Approves Investigational Device Exemption For Efoora HIV Rapid Test
November 19th, 2001
The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) for Efoora, Inc.'s, HIV Rapid Test. The IDE will allow the Efoora HIV Rapid Test to be used in clinical trials that will occur at a number of hospitals and medical facilities throughout the U.S. The clinical data collected during these clinical trials will be submitted to the FDA to support the company's PMA Application for the Efoora HIV Rapid Test. The Efoora HIV Rapid Test is a diagnostic test that is used to screen patients for their HIV status. The result is available in no more than 20...
Source: AIDS Weekly (2001-11-19)
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