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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