IVD Kit definition

IVD Kit means an in vitro diagnostic product for use as a Companion Diagnostic that requires regulatory approval and is sold in a kit form for the purpose of allowing Third Parties to perform an assay, wherein such IVD Kit has been collaboratively developed by the Parties pursuant to this Agreement and one or more IPAs and has successfully received commercial clearance, approval, or registration by one or more regulatory agencies.
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IVD Kit means the QIAGEN IVD, provided in kit format, being developed under this Schedule, which will be commercially available after FDA approves both the NDA (new drug application) for tamibarotene (SY-1425) and the PMA (pre-market application) for the QIAGEN IVD.
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IVD Kit means a kit for use in in-vitro diagnostic testing.
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Examples of IVD Kit in a sentence

  • In-vitro diagnostic medical devices Where the software is provided as part of an IVD system (or IVD kit) it should be treated as an IVDMD.

  • More and more evidence is emerging as to how critical appropriate specimen collection and storage is in the testing process, and the potential impacts it can have on the IVD kit sensitivity.

  • For this purpose, different reagents from an IVD kit are usually mixed during the measurement to start the reaction and produce the required signal.

  • Corrosion-DB refers to weight gain/loss data of high temperature exposed engineering alloys, ceramics and hot isostatic pressed powder materials and covers corrosion tests such as oxidation, sulfidation and nitridation.

  • These had been previously macrodissected using a manual boundary to enrich the sample, followed by DNA extraction using the Roche COBAS DNA Preparation Kit and EGFR mutation status determined by Roche COBAS EGFR IVD kit using COBAS 4800 LightCycler software.

  • In addition, the company’s articles and the last annual report had to be appended to the application.

  • The below tables show the result summary for SARS-CoV-2: Results for the blind contrivance accuracy study using genesig® Real-Time PCR COVID-19 3G CE IVD kit.

  • Indeed, the Geenius™ test is the only FDA-approved differential IVD kit recommended35.

  • From the overall variance between lots, the confidence with which future lots of the IVD kit will detect the panel member at that time point after manufacture and transport can be calculated.

  • Analytical sensitivity with alternative instruments: genesig q32 and Roche LightCycler 480 IIThe SARS-CoV-2 targets are the same as found in the genesig® Real-Time PCR COVID-19 3G CE IVD kit, so for studies of other instruments, please see the IFU at: https://www.genesig.com/products/10061-genesig-covid-19-3g.


More Definitions of IVD Kit

IVD Kit means an IVD Product that is developed in a kit form and that requires Regulatory Approval so that the Commercial Platform may be performed in a de-centralized fashion by LabCorp or by Third Parties.
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IVD Kit means a kitted version of the Assay Developed by IVS pursuant to this Agreement, for Regulatory Approval as a companion diagnostic for the APR Product, to be distributed to its LabPMM laboratories and appropriate third party laboratories to enable LabPMM laboratories and appropriate third party laboratories to perform the IVD per applicable regulations. As used herein, “IVD Kit” shall include improved or subsequent versions of such test kit.
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IVD Kit means a complete diagnostic test for use with the IVD Instrument, which test comprises at least (i) Xxxxx Components that are test-specific elements supplied by Xxxxx (e.g., primers, enzymes); (ii) BioNano Kit Components supplied to Xxxxx by BioNano under this Agreement; and (iii) analysis/interpretation software developed by Xxxxx that will accept IVD Instrument standard output files and operate with the IVD Instrument.
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IVD Kit means a complete diagnostic test for use with the IVD Instrument, which test comprises at least […***…].
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Related to IVD Kit

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

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Development Tool Kit means a DS Offering specifically designed for application or content development. A Development Tool Kit is either identified (i) with “CAA” or “ENOVIA Studio” in the DS Offering name, or (ii) in the Transaction Document and/or the Product Portfolio. Extended Enterprise User means an employee of Customer’s affiliate(s), supplier(s) and/or customer(s) authorized to use Customer’s DS Offering for the sole and exclusive purpose of enabling the Extended Enterprise User(s) to conduct business with Customer. The use of the DS Offering by any such Extended Enterprise User(s) (1) shall be solely limited to use (a) as configured and deployed by Customer and (b) in connection with the Extended Enterprise User’s performance of services for and on behalf of Customer, and (2) shall exclude any use by Extended Enterprise User (a) for its own account or a third party’s account, or (b) for the purpose of modifying, otherwise using, maintaining or hosting the DS Offering. Extended Enterprise Users are authorized if so specified in the Product Portfolio.

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  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • 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;

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • 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.

  • Manufactured products means items and construction materials composed in whole or in part of non-ferrous metals such as aluminum; plastics and polymer-based products such as polyvinyl chloride pipe; aggregates such as concrete; glass, including optical fiber; and lumber.

  • Software Product means any COTS which you propose to provide pursuant to the contract.

  • 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).

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • 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.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • 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.

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

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

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.