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For Research Use Only

Meaning

This mandatory disclaimer, often abbreviated as RUO, is placed on reagents, instruments, or diagnostic assays that are intended strictly for laboratory investigation and not for use in clinical diagnostic procedures. Products labeled RUO have not undergone the rigorous validation and regulatory clearance from bodies like the FDA required for clinical diagnostic tools used to make medical decisions regarding hormonal health. Clinicians and patients must recognize that results derived from RUO-labeled assays are purely for scientific inquiry and cannot definitively guide personalized endocrine therapy. The designation signifies a critical distinction between investigational science and validated clinical practice.