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.

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.

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.
To the extent permitted by PRC laws and regulations, ▇▇▇▇▇ 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 ▇▇▇▇▇.
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.
Subject to the terms and conditions of this Agreement, BioNano agree that ▇▇▇▇▇ may use its Affiliate to manufacture and Sell the IVD Kit and IVD Instrument on behalf of ▇▇▇▇▇.
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 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.
Marketing of IVD Instrument and IVD Kit • All materials referencing BioNano brands must include appropriate trademark acknowledgements.
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.
As used herein, “Authorized Affiliate” means a ▇▇▇▇▇ Affiliate expressly authorized under the Agreement to market and/or Sell the IVD Kit and/or IVD Instrument in the Territory.

More Definitions of IVD Kit

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.

IVD Kit means a kit for use in in-vitro diagnostic testing.

IVD Kit means a complete diagnostic test for use with the IVD Instrument, which test comprises at least (i) ▇▇▇▇▇ Components that are test-specific elements supplied by ▇▇▇▇▇ (e.g., primers, enzymes); (ii) BioNano Kit Components supplied to ▇▇▇▇▇ by BioNano under this Agreement; and (iii) analysis/interpretation software developed by ▇▇▇▇▇ that will accept IVD Instrument standard output files and operate with the IVD Instrument.

IVD Kit means a complete diagnostic test for use with the IVD Instrument, which test comprises at least […***…].