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Are the Nurx STI Home Test Kits approved by the FDA?

Our test kits include laboratory developed tests that do not require individual FDA clearance. The federal government (including the FDA) regulates laboratory testing through a set of rules known as the Clinical Laboratory Improvement Amendments (CLIA). All individual testing components in the Nurx STI Home Test Kits are FDA-cleared for use with serum samples and are validated for use by our partner, Molecular Testing Labs (MTL), a fully licensed CAP and CLIA-certified lab with extensive experience testing for infectious diseases.

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