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FDA warns vs unregistered HIV self-test kit

/ 05:01 AM October 03, 2017

The Food and Drug Administration (FDA) is warning the public against the use of unregistered self-test kits for human immunodeficiency virus (HIV) being advertised and sold online.

In an advisory, the FDA said its postmarketing surveillance on the product, One Step Cassette Style HIV 1+2 Rapid Screen Test, confirmed that it had not gone through the agency’s registration and evaluation process.


“The agency cannot guarantee its quality and safety,” the FDA said. “The public is hereby advised not to purchase the… violative product and to be vigilant against medical device products that are not registered with the FDA.”

The agency directed concerned outlets not to advertise, sell or distribute the product.


Local government units were also advised to report if it continued to be sold in their areas. —Tina G. Santos

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TAGS: FDA, Food and Drug Administration, HIV self-test kit, One Step Cassette Style HIV 1+2 Rapid Screen Test
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