RUO Policy

RUO DEFINITION
“RUO” is an abbreviation for Research Use Only. It is a designation used primarily by the FDA (Food and Drug Administration) for products, often in vitro diagnostic (IVD) components like reagents or instruments, that are in the laboratory research phase of development and are not intended for clinical diagnostic use.

RUO EXPLAINED
Intended Purpose: RUO products are intended solely for basic research, pharmaceutical research, or the development of new tests, not for diagnosing a disease or condition in a patient.

REGULATORY EXEMPTION
Products labeled “For Research Use Only. Not for use in diagnostic procedures” are exempt from most of the FDA’s regulatory requirements for medical devices, such as premarket approval/clearance and Good Manufacturing Practices (GMP). This exemption makes them more cost-effective for research purposes.

LABELING REQUIREMENT
The prominent RUO labeling serves as a critical warning to prevent their use in patient testing.

FDA OVERSIGHT
The FDA determines a product’s intended use based on the “totality of the circumstances,” including labeling, advertising, and sales practices.

Important: All products sold on this site are strictly for research use only. Any use outside of laboratory research is prohibited.