Analyte Specific Reagent definition
Analyte Specific Reagent or “ASR” shall mean the finished, packaged and labeled assembly of a Licensed Product in the form of assay components, purchased by commercial laboratories to test for the detection and/or quantification of an analyte under the United States Code of Federal Regulations, Title 21, Paragraphs 809.10, 809.30, 864.4010 and 864.4020.
Analyte Specific Reagent shall have the meaning ascribed to it by 21 C.F.R. § 809.30 and 864.4020(a), (B - class 1), to include a Class 1 designation.
Analyte Specific Reagent or "ASR" shall mean the finished, packaged and labeled assembly of a Licensed Product in the form of assay components, purchased by commercial laboratories to test for the detection and/or quantification of an analyte under the United States Code of Federal Regulations, Title 21, Paragraphs 809.10, 809.30, 864.4010 and 864.4020.
Examples of Analyte Specific Reagent in a sentence
So long as (i) the conditions of this section 3.4 are met, and (ii) the components supplied to Discovery for use in connection with the Hybrigel Consumable meet Discovery’s supplier qualifications as defined by 21 C.F.R. § 820 (and meet all current and future ASR Regulations, as promulgated), Discovery agrees that it will label the Hybrigel Consumable as an Analyte Specific Reagent.
More Definitions of Analyte Specific Reagent
Analyte Specific Reagent or “ASR” means nucleic acid sequences and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and/or quantification of an individual chemical substance in a biological specimen, as further defined in 21 CFR 864.4020(a), as such regulation may be amended or replaced from time to time, or as defined in equivalent foreign regulations.
Analyte Specific Reagent. OR "ASR" shall mean diagnostic reagents used or sold for use by Third Parties with General Purpose Reagents (GPR) under applicable regulations of the U.S. Food and Drug Administration, where the ASR's and GPR's are not considered to comprise a diagnostic test kit.