The FDA defines analyte specific reagents (ASRs) in 21 CFR 864.4020 as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” In simple terms an analyte specific reagent is the active ingredient of an in-house test. The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ... Wikipedia does not yet have an article with this exact name. ... A representation of the 3D structure of myoglobin, showing coloured alpha helices. ... In chemistry, a ligand is an atom, ion or functional group that is bonded to one or more central atoms or ions, usually metals generally through co-ordinate covalent bond. ... This article or section does not cite its references or sources. ... In chemistry, a ligand is an atom, ion, or molecule (see also: functional group) that generally donates one or more of its electrons through a coordinate covalent bond to, or shares its electrons through a covalent bond with, one or more central atoms or ions (these ligands act as a...

External links

• FDA Guidance for Industry - Analyte Specific Reagents (Small Entity Compliance Guidance), February 26, 2003
• Code of Federal Regulations - Specimen Preparation Reagents (21CFR864.4020)