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