Study Device definition

Study Device means integrated thermal imaging data acquisition system for breast cancer screening, the interpretive algorithm analysis process and the clinical evaluation and display device/software which are to be used or administered during the Study in accordance with the provisions of the Protocol.
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Study Device means any physical item contrived for a specific purpose used in medical treatment that is designed, made, and/or adapted to assist a person to perform a particular task.
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Study Device means device BioMimeTM Sirolimus Drug Eluting Stent System, as available on the medical devices market from Meril and its authorized agents or distributors. The Study Device has the CE Certificate and will be used for certified indications as certified by the CE certificate only.
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Examples of Study Device in a sentence

  • No such response shall contain any false or misleading information with respect to the Study, the Study Device or SPONSOR.

  • The Study Device shall only be used as described in the applicable Protocol and in compliance with Applicable Laws, including those pertaining to Investigational Device Exemptions.

  • The parties acknowledge that the Study Device has not been cleared or approved by the FDA for the indication under investigation in the Study.

  • For each Study, the Institution and Principal Investigator shall notify SPONSOR of any information concerning any device deficiency and any serious or unexpected event, injury, toxicity or sensitivity reaction, and the severity thereof, associated with any Study or any Study Device in accordance with the Protocol for each Study with respect to the reporting of adverse Subject experiences.

  • Unless otherwise provided in the SOW, Study Device is being provided by SPONSOR without charge to Institution, Facility, Subject or other on a Subject’s behalf.

  • The Institution shall maintain complete and accurate records relating to the storage, inventory, and disposition of the Study Device supplied to the Institution, as set forth in Section 11.1.

  • After the term of this Agreement, SPONSOR will provide such information about the safety and use of the Study Device as it provides in the normal course of business to respond to a field action, recall, or other action related to the relevant Study Device (“Post-Study Reporting”).

  • The Institution shall turn over all Study Documentation and materials in its possession associated with the Study, including all Work Product, Inventions and Materials, as expeditiously as possible, shall handle the Study Device in accordance with Section 9 and the instructions of SPONSOR and shall provide such other assistance as is necessary to ensure a smooth and orderly transition of the Study that will not involve any disruption of the Protocol.

  • Please provide certificate/approval details or indicate "pending" below:The Project involves the following (please select all that apply):Certificate/Application Number Certificate/Application Number Humans Pending Animals Clinical Study Drug Biohazardous Materials Clinical Study Device Radioactive Materials Hospital Review Environmental Impact Please login to RISe rise.ubc.ca to submit an amendment to add this Project to an existing approval.

  • Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference in the applicable E-IRB "Study Drug" or "Study Device" section.


More Definitions of Study Device

Study Device means the Delcath System, a double balloon catheter device designed to isolate organs, including the liver, from the general circulatory system during liver cancer treatments with chemotherapy and which returns blood exiting the liver to the general circulatory system only after the chemotherapeutic has been substantially removed by filtration.
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Study Device means a device for collection of patients’ breath samples for subsequent analysis via one or more analytical means, including Company’s mass spectrometry (MS) technology, and may include one or more devices (i) provided by Company (“Company Study Device”), (ii) provided by Institution, and/or (iii) obtained from commercial sources (the latter two collectively, “Other Study Device”).
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Study Device means the Spectroscopic Guidewire System (comprised of the Spectroscopic Diagnostics System console, proprietary system software, and the disposable optical core Spectroscopic Guidewire) provided by SpectraScience for the Study at General.
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Study Device as used herein shall mean the BLU-U™ brand device or other device being tested in a Study as described in a Protocol.
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Study Device means all Study medications or Study medical devices provided by the Sponsor to be utilized by PAREXEL in the execution of a Study, as set forth in the applicable Protocol.
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Related to Study Device

  • Assistive technology device means any item, piece of equipment, or product system that is used to increase, maintain, or improve the functional capacities of a child with a disability.

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • 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.

  • Security Device means any passwords, User identification numbers, certificates, or other form(s) of authentication or security used to access the Service.

  • Spot-film device means a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of an image intensifier for the purpose of making a radiograph.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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:

  • 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.

  • Control device means equipment (such as an incinerator or carbon adsorber) used to reduce, by destruction or removal, the amount of air contaminants in an air stream prior to discharge to the ambient air.

  • Prosthetic device means a replacement, corrective, or supportive device, other than contact lenses and dental prosthesis, dispensed pursuant to a prescription, including repair or replacement parts for that device, worn on or in the body to do 1 or more of the following:

  • Defeat device means any element of design which senses temperature, vehicle speed, engine rotational speed, drive gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any part of the emission control system that reduces the effectiveness of the emission control system under conditions which may reasonably be expected to be encountered in normal vehicle operation and use. Such an element of design shall not be considered a defeat device if:

  • Encapsulation means the application of an encapsulant.

  • Assistive device means any item, piece of equipment, or product system which is used to increase, maintain, or improve the functional capabilities of an individual with a disability in the workplace or on the job. “Assistive device” does not mean any medical device, surgical device, or organ implanted or transplanted into or attached directly to an individual. “Assistive device” does not include any device for which a certificate of title is issued by the state department of transportation, but does include any item, piece of equipment, or product system otherwise meeting the definition of “assistive device” that is incorporated, attached, or included as a modification in or to such a device issued a certificate of title.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Device means instruments, apparatus, and contrivances, including their components, parts, and

  • Encapsulant means a substance that forms a barrier between lead-based paint and the environment using a liquid-applied coating (with or without reinforcement materials) or an adhesively bonded covering material.

  • Assisted amusement device means an amusement device, skill device, or ride

  • Tracking device means equipment that records the location, whether directly or indirectly, of Employees, whether by the use of equipment that uses Global Positioning System (GPS) or by another like means.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Incendiary device means any firebomb, and any device designed or specially adapted to cause physical harm to persons or property by means of fire, and consisting of an incendiary substance or agency and a means to ignite it.

  • 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.

  • Access Device means a card, plate, code, account number, per- sonal identification number, electronic serial number, mobile identi- fication number, or other telecommunications service, equipment, or instrument identifier or means of account access that alone or in conjunction with another device may be used to:

  • Fabrication means making up data or results and recording or reporting them.