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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

You have Leber's disease (hereditary optic atrophy)

These results directly confirm that excessive NNMT activation suppresses NAD+ synthesis and impairs energy metabolism, while NNMT inhibition effectively reverses this process, establishing NNMT as a negative regulator of energy metabolism

If you have one of those conditions, getting B12 injections can prevent a deficiency before it starts