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IVD Test Reagent/Kits, Serology, Standard, Bacteria

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 pathogenic bacteria are compared. These standards may be used to determine the purity or performance of immunoassay reagents used in infection tests to determine bacteria.

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

UMDC code : 19463

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