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IVD Test Reagent/Kits, Immunoassay

Definition : Reagents intended for use in a diverse range of sensitive and specific clinical assays using immunochemical reactions (immunoassays). The specificity and high affinity of antibodies for specific antigens, coupled with the ability of antibodies to cross-link antigens, allows the identification and quantification of specific substances using a variety of methods. Some of these reagents are available in kits that include an antibody or antigen, calibrators, and other specific reagents (e.g., activator). Immunoassay reagents may be specific for one or many different types of assays, such as electrophoresis, nephelometry, or microtiter assays. They are used in a variety of tests to determine levels of proteins, hormones, drugs of abuse, and many other substances, facilitating the diagnosis of allergies, autoimmune diseases, tumors, and other conditions.

Entry Terms : "Immunochemistry Reagents" , "Immunoassay Reagents" , "Reagents, Radioimmunoassay" , "Reagents, Fluorescence Immunoassay" , "Reagents, Enzyme Immunoassay" , "Reagents, Immunoassay"

UMDC code : 19085

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