Regulatory
Research Use Only (RUO) Disclaimer
Important Notice
All products sold by AGERE are intended for research use only and are not for use in humans or animals. These products are not approved by the FDA or any other regulatory agency for diagnostic or therapeutic use.
What "Research Use Only" Means
The RUO designation is an FDA-recognized classification for laboratory materials used in basic scientific research. Products labeled RUO have not undergone the clinical trials, safety reviews, or regulatory approval processes required for drugs, biologics, or medical devices intended for human or animal use.
Who May Purchase
Our products are sold to qualified researchers, scientists, and institutional buyers for legitimate in vitro and preclinical laboratory research. Purchasers must be 21 years of age or older and must confirm at checkout that they are purchasing for authorized research purposes.
Prohibited Uses
- Human consumption or administration of any kind.
- Animal administration outside an approved research protocol.
- Diagnostic, therapeutic, prophylactic, or cosmetic use in humans or animals.
- Resale to consumers or end-users without appropriate institutional controls.
Buyer Responsibility
Purchasers assume full responsibility for the lawful and compliant use of all materials purchased from AGERE. AGERE shall not be liable for any misuse, non-compliant use, or harm resulting from use outside the RUO designation.
Regulatory References
Our operations are conducted in accordance with 21 CFR Part 801 labeling requirements and relevant FDA guidance for research-use materials. Our COA documentation standards follow ICH Q7 principles.