Clinical Diagnostics definition

Clinical Diagnostics means all testing to detect, identify, and/or quantitate one or more nucleic acid sequences for the purposes of detecting, diagnosing, making prognoses, monitoring, treating, preventing, or studying Human Disease. As used herein, “Human Disease” means any aberration of structure or function of any human cell, tissue or organ, living or dead. Without limiting the generality of the foregoing, Clinical Diagnostics includes testing in human clinical trials.
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Clinical Diagnostics means the performance of FDA-approved clinical diagnostic test(s) on a human tissue or other human biological sample, the results of which are provided to health care providers for use in the clinical management of individual patients.
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Clinical Diagnostics means, in the clinical medical practice, the assaying, testing or determination of, inside or outside of a living human or animal, one or more biomarkers in or on any test sample for the purpose of identifying, characterizing, defining or diagnosing a disease state (including, without limitation, determining the state of health of a human or animal) to identify, treat or prevent disease, as well as the screening, prognosis, therapeutic monitoring and/or evaluation of the progression of any disease. For the avoidance of doubt, if an assay is being performed on a living animal, or on animal tissue or other sample derived from a living animal, for the purpose of food testing, such application shall not be considered a Clinical Diagnostic.
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Examples of Clinical Diagnostics in a sentence

  • Instruments are on service contract and except for the routine daily, weekly and monthly maintenance are serviced by an Ortho Clinical Diagnostics technical representative.

  • Description of Business Business SegmentsToday, Bio-Rad operates in two industry segments designated as Life Science and Clinical Diagnostics.

  • Targeted Next-Generation Sequencing can Replace Sanger Sequencing in Clinical Diagnostics.

  • The acquisition was included in our Clinical Diagnostics segment's results of operations from the acquisition date and was accounted for as a business combination.

  • This business acquisition is included in our Clinical Diagnostics segment's results of operations from the acquisition date.

  • The Clinical Diagnostics segment develops, manufactures, sells and services automated test systems, informatics systems, test kits and specialized quality controls for the healthcare market.

  • Prior to that, he was the Clinical Diagnostics U.S. National Sales Manager since joining Bio-Rad in 1998.

  • Clinical Diagnostics Segment Our Clinical Diagnostics segment designs, manufactures, sells and supports test systems, informatics systems, test kits and specialized quality controls that serve clinical laboratories in the global diagnostics market.

  • Previously he was Vice President, Commercial Manager, Europe from 2012 to 2014 and Commercial Manager, Clinical Diagnostics Group, Europe from 2011 to 2012 and Division Manager of the Clinical Diagnostics Group North American Sales Organization from 2008 to 2011.

  • Pursuant to the Business Combination Agreement, dated as of December 22, 2021 (the "Business Combination Agreement") by and among Quidel Corporation ("Quidel"), Ortho Clinical Diagnostics Holdings plc, QuidelOrtho Corporation ("QuidelOrtho"), Orca Holdco, Inc., Laguna Merger Sub, Inc.


More Definitions of Clinical Diagnostics

Clinical Diagnostics. ("cDx"): shall mean test(s) performed on a human tissue or other human biological sample, the results of which are provided to payors, providers, or patients for use in the clinical management of individual patients, which become part of such patient's health record; provided, however, that Clinical Diagnostics shall expressly exclude test(s) performed on human tissue or other human biological sample in the course of Phase I, II, III or IV clinical trials for an ethical pharmaceutical.
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Clinical Diagnostics shall have the meaning set forth in the Cross License Agreement of even date herewith between the parties.
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Related to Clinical Diagnostics

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Director means an individual who meets the minimum requirements set forth in Title 9, CCR, and has at least two (2) years of full-time professional experience working in a mental health setting.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Diagnostic Services means services provided for the purpose of determining the nature and cause of a condition, ill- ness, or injury.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Novartis shall have the meaning set forth in the Preamble.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Therapeutic school means a residential group living facility:

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;