RE:RE:RE:SONA mentioned in this article
some clarification; it's called a "research use only" product until FDA approval. Article Navigation Research Use Only Reagents: Is There an Imperative for Increased FDA Oversight? Timothy J O'Leary Clinical Chemistry, Volume 57, Issue 12, 1 December 2011, Pages 16811683, https://doi.org/10.1373/clinchem.2011.174268 Published: 01 December 2011 Article history pdfPDFSplit ViewCite Permissions Share Issue Section: OPINIONS On June 1, 2011, the US Food and Drug Administration (FDA)2 Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance for industry and FDA staff intended to provide guidance regarding the FDA's thinking about in vitro diagnostic device (IVD) products labeled for Research Use Only (RUO) or Investigational Use Only (IUO) (1). Reagents may be marketed under either of these labels without FDA premarket review and are partially or totally exempt from compliance with the Quality Systems Regulation (21 CFR 820).