Analyte Specific Reagents definition

Analyte Specific Reagents 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 may be amended or replaced from time to time, or in equivalent foreign regulations.
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Analyte Specific Reagents. (or "ASRs") shall mean 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 for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition shall not fall within this definition when they are sold to (i) in vitro diagnostic manufacturers for the purpose of manufacturing in vitro diagnostic products, or (ii) organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other non-clinical laboratories.
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Examples of Analyte Specific Reagents in a sentence

  • Title: Interim Director Title: VP, IP and Legal Affairs Date: February 22, 2007 Date: 2/28/2007 Fields of Use: Human clinical diagnostics field, including Research Use Only (RUO), Investigational Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (IVD) fields of use for anticoagulant dosing.

  • EXACT shall provide to Discovery all documents as appropriate and necessary for Discovery to comply with all applicable governmental laws, requirements and regulations relating to manufacturing using Analyte Specific Reagents, including without limitation, compliance with the requirements under 21 C.F.R. § 809.30 and 864.4020 and QSR requirements under 21 C.F.R. § 820.

  • The Contractor shall produce Analyte Specific Reagents (ASR) or FDA approved test kits appropriate for genotyping the CFTR gene which conforms to the SCMG list of 23 mutations and should also include additional population specific mutations.

  • Gen-Probe and its Affiliates shall, to the extent permitted by law (e.g., without limitation, regulatory, e.g., US FDA, requirements such as pertaining to Analyte Specific Reagents), include on or with each Licensed Product directed to HCV a statement as to the number of Units contained within each such Licensed Product, using such language to be determined by Gen-Probe and approved in advance in writing by Bayer, which approval shall not be unreasonably withheld.

  • Fields of Use (sections 1.2 and 3.1.1): Fields of Use: Human clinical diagnostics field, including Research Use Only (RUO), Investigational Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (IVD) fields of use for anticoagulant dosing.

  • The Contractor must produce Analyte Specific Reagents (ASR) or FDA approved test kits appropriate for genotyping the CFTR gene which conforms to the ACMG list of 23 mutations and must include additional population specific mutations already in the Michigan test panel.

Related to Analyte Specific Reagents

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