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.

  • Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.

  • The agenda for the Advisory Board meeting includes Presentation of SEC Petitions for Oak Ridge Institute of NuclearDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. 2006D–0336] Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; AvailabilityAGENCY: Food and Drug Administration, HHS.ACTION: Notice.ASR manufacturers.

  • In the United States, primers and probes for viral and bac- terial targets are available as Analyte Specific Reagents (ASRs) for use as components in clinical- laboratory, self-validated PCR test methods.

  • The me- chanical properties of materials used in the present work are given in table 1.

  • 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 end-user inputs extracted genomic DNA to be sequenced and provides the Analyte Specific Reagents (ASRs) to develop a sequencing assay that targets their sequence of interest.

  • 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 21C.F.R. § 820.

  • The 14 targets detected by the kit are also available as Analyte Specific Reagents (ASRs) in the USA.

  • These reagents, regulated under the Analyte Specific Reagents (ASR) guidelines, are meant to be used by in vitro diagnostic manufacturers, clinical laboratories (which bear the responsibilities associated with the development of tests made with ASRs) or organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners.

Related to Analyte Specific Reagents

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