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[DOI] [PubMed] [Google Scholar] 115.Eigner W., Bashir K., Primas C., Kazemi-Shirazi L., Wrba F., Trauner M., Vogelsang H

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