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.
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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.
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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.
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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.
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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.
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Related to Analyte Specific Reagent

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

  • Brand name specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Product Specification means the document referred to in:

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time. The Contract Specifications appear on the Website.