Decision Diagnostics Corp (DECN)

[Raffis]

“..an RUO is essentially unregulated by FDA.”

In any event, aside from bearing the mandated statement, RUO products are not regulated by the agency. For example, they do not need to be listed with FDA or comply with the Quality System Regulation (QSR). They can be sold without any FDA clearance or approval. As a practical matter an RUO is essentially unregulated by FDA.
https://www.genengnews.com/magazine/129/oversight-of-research-use-only-products/

“As a practical matter an RUO is essentially unregulated by FDA.”