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IVD Test Reagent/Kits, Serology, Standard

Definition : Serology reagents consisting of a substance (e.g., a solution) that is established as a norm with which similar reagents used in tests performed to determine antigens and/or antibodies in human specimens due to infection by pathogenic microorganisms (e.g., viruses, bacteria, parasites) are compared. These standards may be used to determine the purity or performance of immunoassay reagents used in infection tests.

Entry Terms : "Standard Reagents, Serology" , "Reagents, Serology, Standard"

UMDC code : 19082

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