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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

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

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Nutrients 2019;11:2617

Vitamin B12, also called cobalamin, is a water-soluble vitamin critical to various physiological processes