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

  • In such case, the Parties will negotiate in good faith, for a period not to exceed [***], commercially reasonable terms and conditions pursuant to which such other Party would grant to such Party a license or the right to Develop, manufacture and Commercialize such Diagnostic Kit for such purposes.

  • 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 ▇▇▇ ▇▇▇▇ (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.

  • 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.

  • If either Party desires to obtain a license under intellectual property rights Controlled by the other Party to Develop and Commercialize a Diagnostic Kit containing Biomarker Technology outside of the scope of the licenses granted under Article 5, such Party shall notify the other Party in writing setting forth a specific proposal for the type of Diagnostic Kit it desires to Develop and Commercialize.

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

  • Buyer shall have the sole responsibility of obtaining and maintaining all governmental or regulatory licences, authorisations, registrations and clearances for use and sale of the Diagnostic Kit.

  • If there is a Required Diagnostic Kit with respect to the Licensed Product, and Mersana is not the entity selling such Required Diagnostic Kit, then, in lieu of being required to supply such Required Diagnostic Kit to Recepta, Mersana will use Diligent Efforts to assist Recepta in obtaining direct supply of any such Required Diagnostic Kit from Mersana’s Third Party partner, if any, for such Required Diagnostic Kits.

  • Subject to the terms and conditions of this Agreement, LUMINEX appoints MIRAI as a distributor (i) in the [__]* and Instrument Territory of (a) Luminex Systems and (b) [__]*, (ii) in the Research Kit Territory of Eligible Kits and Tests designed and sold solely for use in the Research Field, and (iii) in the Diagnostic Kit Territory of Eligible Kits and Tests designed and sold solely for use in a Diagnostic Field.

  • The transfer price to be paid by Naroo for each Product (Onko-Sure DR-70 Diagnostic Kit) shall be five hundred US dollars ($500.00).

  • Seller expressly disclaims any representations and warranties regarding the performance, safety and efficacy of the Antibodies in combination with the Product or the Diagnostic Kit.

Related to Diagnostic Kit

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • 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: