home-testing
Every record this desk has filed under home-testing, newest first, each with the number of sources it can still show you.
FDA codifies home-collected STI test controls, including laboratory shipping and warnings about negative results
FDA's October 9 order codifies controls for tests that use specimens collected at home to detect non-viral organisms causing sexually transmitted infections. Testing takes place in a clinical laboratory, and the box must make that shipping step clear. The classification dates to November 2023. Required warnings say negative results do not rule out other pathogens and the system does not replace a healthcare visit.
Also filed underhealthsexually-transmitted-infectionsmedical-devicesfdafederal-register
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