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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Examples of Diagnostic Kit in a sentence

  • 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).

  • No royalties shall be paid on sales of Complete Diagnostic Kits between LCE and its Affiliates, when the Affiliate is not the End User of such Complete Diagnostic Kit, but acts as LCE’s distributor.

  • 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).

  • In such event royalties shall be due and payable on the Net Sales of such Complete Diagnostic Kit by such Affiliates to third parties.

  • Patients with other diseases or negative persons with negative nucleic acid test results by using Diagnostic Kit: RapidFor™ Coronavirus (SARS-CoV-2) Saliva Antigen Detection Kit (Collaidal Gold),developed by Vitrosens Biotechnology.

  • The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is intended for use by qualified, trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

  • The performance of the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR- Fluorescence Probing) was established using nasopharyngeal/oropharyngeal swabs.

  • The parties understand that NISB’s 51% owned subsidiary, TRI-G is the company registered under Medical Device Authority (MDA), Ministry of Health, Malaysia and licensed to operate under the Medical Device Xxx 0000 (Act 737) shall be in the best endeavours to obtain the necessary approval and license for the Diagnostic Kit to be distributed in Malaysia and in Indonesia.

  • Diagnostic Kit for Immunoglobulin G4 (Chemiluminescence Immunoassay) (免疫球蛋白G4測定試劑盒(化學發光法)) and its supporting calibrators and quality control products obtained registration certificates in June 2022.

  • The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real- time reverse transcription polymerase chain reaction (rRT-PCR) test.

Related to Diagnostic Kit

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • 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 a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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 a service provided using Licensed Products or Licensed Methods, including, without limitation, any such service provided in the form of contract research or other research performed by Licensee on behalf of a third party.

  • 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 [***].

  • 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: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

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

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.

  • 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

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

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.