Research Use Only

What does "Research Use Only" mean?

The RUO designation indicates that a product is intended exclusively for in vitro laboratory research by qualified scientific personnel. RUO products have not been validated for diagnostic, clinical, therapeutic, or any other use. They are not subject to FDA premarket approval pathways applicable to medical devices or drugs.

Who can purchase RUO products?

RUO products are intended for purchase by qualified researchers, laboratory professionals, and institutions engaged in scientific research. By completing a purchase, customers represent that they are qualified to handle research materials and that they will use products exclusively for legitimate research purposes in appropriate laboratory settings.

Are RUO products FDA-approved?

No. RUO products have not been evaluated or approved by the U.S. Food and Drug Administration. They are not intended to diagnose, treat, cure, or prevent any disease or condition. No claims to the contrary should be inferred from any product name, description, or ingredient listing.

What is the regulatory basis for RUO classification?

The RUO designation is established under 21 CFR 809.10(c) for in vitro diagnostic products intended for research use only. Adapt Aminos products fall outside the scope of FDA regulation applicable to consumer products, dietary supplements, or drugs, provided they are used exclusively as labeled.

What are my obligations as a purchaser?

Purchasers are solely responsible for ensuring that their use of RUO products complies with all applicable federal, state, and local laws and regulations. This includes proper handling, storage, disposal, and documentation requirements applicable to their institution or jurisdiction.

Can RUO products be used in humans or animals?

No. Adapt Aminos products are strictly for in vitro (cell-free or cell-based) laboratory research. They must not be administered to humans or animals under any circumstances. Use in humans or animals, regardless of context, is strictly prohibited and inconsistent with the RUO classification.