Alere Inc Receives FDA Approval For Alere Determine HIV-1/2 Ag/Ab Combo
Alere Inc announced that it has received U.S. Food and Drug Administration (FDA) approval of its pre-market application (PMA) to market Alere Determine HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2. The FDA approval allows Alere to market Alere Determine HIV 1/2 Ag/Ab Combo as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device.
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