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Conjugation is typically achieved via chemical linkers, adding another layer of complexity to characterization and control, as well as necessitating highly selective and sensitive analytical methods to accurately assess the modified species and ensure consistent product quality

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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