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

  • Analyte Specific Reagents (ASRs)FDA is generally enforcing applicable regulatory requirements for components of IVDs even if the agency is exercising enforcement discretion for the complete test.

  • Laboratory-developed tests (LDTs) are not currently regulated by the FDA in the way that test kits are and, therefore, the clinical validity of the majority of genetic tests is not regulated.The FDA does currently regulate certain components used in LDTs, known as Analyte Specific Reagents (ASRs), but only if the ASR is commercially available.

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

  • In July, Epoch launched 21 MGB Eclipse detection reagents, real-time Analyte Specific Reagents (ASRs) for the molecular diagnosis of infectious and genetic diseases and cancer.

  • 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.

  • 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.

  • Indeed, there are more reasons to think that harmony deserves the epithet “Patron of Pluralism” than there are to consider it as “Origin of Totalitarianism.”This special issue collects seven papers that explore the concept of harmony and its implications in various perspectives, drawing on philosophical resources from both eastern and western as well as analytic and continental traditions.

  • 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 District reserves the right to modify this proposal or reject any bids at its sole discretion.

  • EXACT shall comply with and give all notices required by, all laws, ordinances, rules, regulations and lawful orders of any public authority bearing on the performance of this Agreement or the design, manufacture, marketing, sale and use of the Hybrigel Consumables, provided that in relation to United States governmental laws, requirements, and regulations that relate to Analyte Specific Reagents, EXACT shall be able to rely on Discovery’s compliance with section 6.1.6 above.

Related to Analyte Specific Reagents

  • Service Specifications means the following documents, as applicable to the Services under Your order:

  • 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.

  • 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.

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • API means American Petroleum Institute.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Analyte means a chemical, compound, element, bacteria, yeast, fungus, or toxin to be identified or measured.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Manufacturing Process means any process for—

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Service Specific Terms has the meaning given in the G Suite Agreement or Complementary Product Agreement, as applicable, or, if Customer’s G Suite Agreement does not define “Service Specific Terms”, means the then-current terms specific to one or more Core Services for G Suite set out at xxxxx://xxxxxx.xxxxxx.xxx/terms/service-terms/.