IVD Kit definition

IVD Kit means an in vitro diagnostic product that requires regulatory approval and is sold in a kit form for the purpose of allowing third parties to perform a test.
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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 kit for use in in-vitro diagnostic testing.
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Examples of IVD Kit in a sentence

  • FMI shall not, and shall cause its Affiliates not to, grant any third party any rights with respect to any IVD Kit Product that conflict with or otherwise limit any of the rights granted (or contemplated to be granted) to Roche and its Affiliates under this Agreement or any IVD Agreement.

  • As used herein, “Authorized Affiliate” means a Xxxxx Affiliate expressly authorized under the Agreement to market and/or Sell the IVD Kit and/or IVD Instrument in the Territory.

  • Xxxxx is entitled to obtain the Regulatory Approvals on its behalf under Xxxxx’x name and brand collectively or respectively for the IVD System, IVD Instrument, and IVD Kit.

  • The Marketing and Sales Plan will specify the marketing and sales programs that LabCorp will initiate in connection with the commercial launch of the IVD Product and IVD Kit and will provide for appropriate integration of the IVD Product and IVD Kit into LabCorp’s existing sales and marketing infrastructure.

  • Xxxxx’x sole discretion to brand as Xxxxx IVD Kit or co-brand as a BioNano | Xxxxx IVD Kit.

  • All advertising and educational materials relating to the Commercial Platform and related materials shall be prepared by LabCorp (or its subcontractors), and such materials related to the IVD Product or IVD Kit shall be subject to reasonable approval by ARCA and any such materials for different versions of the IVD Product or IVD Kit shall be consistent.

  • Any such materials for the Homebrew Assay shall not be inconsistent with materials relating to the Drug Product, the IVD Product, or the IVD Kit, or to applicable laws as interpreted and enforced by Regulatory Authorities.

  • The Parties shall exercise commercially reasonable efforts in performing their obligations under the IVD Collaboration, including in connection with the evaluation of proposals to develop and commercialize IVD Kit Products.

  • To the extent permitted by PRC laws and regulations, Xxxxx may determine the terms of the warranty it provides for the IVD Kit in its discretion; provided that, such warranty does not exceed the warranty on the BioNano Kit Components provided by BioNano to Xxxxx.

  • LabCorp will use commercially reasonable efforts to conduct the commercialization activities relating to the Commercial Platform in accordance with the timetables and other provisions of the Commercialization Plans and will integrate such activities into LabCorp’s existing sales, marketing and distribution infrastructure to support the sale and distribution of the IVD Product and IVD Kit throughout the Territory.


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 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 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

  • 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.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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,

  • 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.”

  • 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;

  • Licensed Product means any pharmaceutical product that contains a Licensed Compound, either alone or with one or more other pharmaceutical ingredients, and including all formulations, line extensions and modes of administration thereof.

  • 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.

  • 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.

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  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • 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 any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.