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IVD Test Reagent/Kits, Serology, Standard, Virus

Definition : Reagents consisting of substances of known composition, the value of which is established by an analytic procedure different from that used in the clinical laboratory and that are established as a norm with which similar reagents used in serologic tests performed to determine antigens and/or antibodies in human specimens due to infection by a pathogenic virus are compared. These standards may be used to determine the purity or performance of immunoassay reagents used in infection tests to determine viruses.

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

UMDC code : 19464

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