Diagnostic Kit definition

Diagnostic Kit means a product containing reagents and other items necessary to conduct a test to detect the presence of or to measure a given Biomarker in a given Patient Sample.
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Diagnostic Kit means an In Vitro Diagnostic Product for which pre-market regulatory clearance is required by the FDA in the United States, or the equivalent agency responsible for regulating such products in another market. Review of analytical and clinical validity of a Diagnostic Kit is done prior to the marketing of the test system, and therefore, prior to the use of the test system on patient specimens in the clinical diagnosis/treatment context (clinical validity refers to the accuracy with which the Diagnostic Kit identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient). In the United States, pre-market regulatory clearance is obtained via one of three paths: (a) Sl0(k) (the new test can be shown to be substantially equivalent to an existing predicate test on the market), (b) premarket approval (PMA) (the new diagnostic technology cannot be considered substantially equivalent to an existing technology), or (c) de novo reclassification (no predicate device exists and the test is oflow or moderate risk).
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Diagnostic Kit means an In Vitro Diagnostic Product for which pre-market regulatory clearance is required by the FDA in the United States, or the equivalent agency responsible for regulating such products in another market. Review of analytical and clinical validity of a Diagnostic Kit is done prior to the marketing of the test system, and therefore, prior to the use of the test system on patient specimens in the clinical diagnosis/treatment context (clinical validity refers to the accuracy with which the Diagnostic Kit identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient). In the United States, pre-market regulatory clearance is obtained via one of three paths:
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Examples of Diagnostic Kit in a sentence

  • COVID-19 Challenge - Point of Care and Home Diagnostic Kit for COVID-19 o Please visit following link for further details: https://www.ic.gc.ca/eic/site/101.nsf/eng/00096.html o Additionally, NRC IRAP has been tasked by the Government of Canada to work with Canadian industry to address a range of medium‑term Public Health Agency of Canada and Health Canada needs, including:i.

  • Comparator method All samples was confirmed by RT-PCR, Novel Coronavirus (2019-nCoV) Nucleia Acid Diagnostic Kit (PCR-Fluorescence Probing) manufactured by Sansure BioTech Inc.

  • COVID-19 Challenge - Point of Care and Home Diagnostic Kit for COVID-19 o Please visit following link for further details: https://www.ic.gc.ca/eic/site/101.nsf/eng/00096.html o Additionally, NRC IRAP has been tasked by the Government of Canada to work with Canadian industry to address a range of medium‑term Public Health Agency of Canada and Health Canada needs, including: i.

  • All nasopharyngeal samples were confirmed using the Novel Coronavirus 2019-nCoV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (US FDA EUA authorized).

  • The John Radcliffe Hospital, Oxford performed an evaluation as part of their asymptomatic staff screening service using the Respiratory Diagnostic Kit Evaluation (‘Red Kite’) study (Research Ethics Committee reference: 19/NW/0730; North West-Greater Manchester South Research Ethics Committee).

  • Students will have an opportunity to explore different careers, savings and investment options, credit and debt dangers, budgeting, insurance research, and real estate/housing options.

  • One of the kits used with HybriMax is the next generation 37 HPV GenoArray Diagnostic Kit, which can simultaneously detect 37 HPV genotypes in a single run.

  • Riester 3.5V Diagnostic Kit with an EliteVue Macro-Otoscope, coaxial ophthalmoscope(model #RSTR-2210-203.001) with add-on Welch Allyn Pan-optic ophthalmoscope head and Riester Insufflator Bulb (model # RSTR-10960).

  • Total Intact PTH Coated Tube Diagnostic Kit contains the PTH standards prepared analytically on a mass basis from purified synthetic intact PTH (1-84).

  • The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens.

Related to Diagnostic Kit

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Diagnostic x-ray system means an x-ray system designed for irradiation of any part of the human or animal body for the purpose of diagnosis or visualization.

  • Diagnostic mammography means a method of screening that

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • Diagnostic Service means an examination or procedure performed to obtain information regarding the medical condition of an outpatient.

  • 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:

  • Licensed Services means all functions performed by the Licensed System.

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached.

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Therapeutic school means a residential group living facility:

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed Service means performance of a service for any consideration using a Licensed Product, or the practice of a Licensed Process. For clarity, research and development of Licensed Products by Licensee, its Affiliates, or a Sublicensee does not constitute a Licensed Service.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • 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.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • 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.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

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

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.