MANILA — The Food and Drug Administration (FDA) has warned the public against using unregistered home self-test kits for human immunodeficiency virus (HIV) that are sold online.
Based on its Advisory 2017-271, the FDA identified the product as the One Step Cassette Style HIV 1+2 Rapid Screen Test (whole blood).
The FDA said the medical device has not been registered with the office and has not been evaluated, thus, its quality and safety could not be guaranteed.
It directed concerned establishments not to advertise, sell, or distribute the product or face regulatory actions and sanctions, and called on local governments and law enforcers to ensure that the product is not sold or made available in their localities. FDA-northboundasia.com