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

  • Plastics materials, is taken to include other polymeric materials such as rubber.” 6.1.3.1 (a) Replace the first sentence after the symbol with: "This symbol shall not be used for any purpose other than certifying that a packaging complies with the relevant requirements in Chapter 6.1, 6.2, 6.3, 6.5 or 6.6.".

  • 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.

  • 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Ridge Institute of NuclearDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. 2006D–0336] Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; AvailabilityAGENCY: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.

  • 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 vendor 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.

  • 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.

  • Figure 3 sflows a series of typical grey-scale images of a 0.4 Kz plunging breaking wave captured by a monocflrome digital camera at six different pflases at one station, wflerepflases sflow tfle trougfl part of tfle wave wflicfl is not as dynamic, so vorticity results only for tfle six pflases presented.

  • 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.

  • 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.

  • FDA, Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (2007), available at http://www.fda.gov/downloads/Medi- calDevices/DeviceRegulationandGuidance/Guid- anceDocuments/UCM071269.pdf.

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