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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
S.ChenJ.LongneckerR.JardetzkyT
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Patients with a history of autoimmune problems also are more likely to have autoantibodies against intrinsic factor and have reduced B12 uptake
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