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On Nov. 15, the FDA granted marketing authorization for adults to use the over-the-counter Simple 2 Test for gonorrhea and chlamydia, from the home-testing company LetsGetChecked. The test kit ...
Website. oraquick.com. OraQuick is an at-home HIV test manufactured by Orasure Technologies that was approved by the United States Food and Drug Administration in 2012. [1] It is one of only two at-home HIV tests available. [2] OraQuick can be purchased by anyone above aged 17 over-the-counter at any major retail stores or online. [1][3]
Business is booming for the at-home diagnostic test kit industry, which pulls in more than $5 billion a year —a number that’s predicted to double by 2032. Everyone wants in on the action. In ...
In 2012 the U.S. Food and Drug Administration announced that it had approved the first, over-the-counter (OTC) sale of home HIV test kits that do not require sending sample to a lab. [14] [15] The Pennsylvania-based Orasure Company holds the patent and monopoly on the oral swab technology. [16]
In 2004, the US Federal Trade Commission asked Federal Express and US Customs to confiscate shipments of the Discreet home HIV test kits, produced by Gregory Stephen Wong of Vancouver, Canada. [47] In February 2005, the US FDA issued a warning against using the rapid HIV test kits and other home use kits marketed by Globus Media of Montreal ...
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