In Vitro Diagnostic definition

In Vitro Diagnostic means a product or service for in vitro testing of patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a disease or for the prediction or monitoring of a response to any Therapeutic Product (or other agent) or other prognostic use.

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In Vitro Diagnostic or “IVD” means a product or service for in vitro testing of patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a disease, including to identify any genomic alterations or signatures, or for the prediction or monitoring of a response to any therapeutic agent or other prognostic use, whether used for research, exploratory purposes, or as a clinical diagnostic. The term “IVDs” includes “Investigation Use Only” products, Companion Diagnostics, and other IVDs.

In Vitro Diagnostic means a product or service for in vitro testing of patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a disease, medical condition or state of health, including to identify any genomic alterations or signatures, or for the prediction or monitoring of a response to any Therapeutic Product (or other treatment) or other prognostic use, whether used for research, exploratory purposes, or as a clinical diagnostic. For clarity, the term IVD includes IUOs, RUOs, Companion Diagnostics, Complementary Diagnostics and other IVDs.

Examples of In Vitro Diagnostic in a sentence

• STRATEC is engaged in and has expertise and experience in consulting for and the design, development, and manufacture of In Vitro Diagnostic analytical systems and components therefore.

• Varian will reasonably cooperate with and provide all reasonably requested information and assistance for such Approvals, including, without limitation, all information and records required for FDA Approval and the European Community In Vitro Diagnostic Directive.

• CONTRACT GIVER is responsible for the compliance with all applicable regulatory legal requirements to fulfill its obligations under the European Union Medical Device Regulation 2017/745 and the European Union In Vitro Diagnostic Medical Devices Regulation 2017/746 referring to its Distributor role.

• Notwithstanding anything herein to the contrary, all other terms and conditions of the license granted herein under the ABC Patent Rights, including without limitation the royalties to be paid pursuant to Section 3.1 (b) and other restrictions placed on Licensee with respect to activities in the Field, shall continue to apply to the such activities in the Field (whether or subject to this Section 2.10 such activities are in the Human In Vitro Diagnostic Field).

• STRATEC is engaged and has expertise and experience in consulting for and the design, development, and manufacture of In Vitro Diagnostic analytical systems and components therefore.

• For clarity, to the extent they are inconsistent with ISO 13485, the requirements of 21 CFR Part 820 and In Vitro Diagnostic device directive 98/79/EC or the successor In Vitro Diagnostic Regulation will continue to apply to the manufacture of Products hereunder.

• Title: Interim Director Title: VP, IP and Legal Affairs Date: February 22, 2007 Date: 2/28/2007 Fields of Use: Human clinical diagnostics field, including Research Use Only (RUO), Investigational Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (IVD) fields of use for anticoagulant dosing.

• CONTRACT GIVER is acting as Distributor of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD), hereafter called Devices for the Italian market.

• The Complaint Report shall include, as applicable, an initial assessment of Medical Device Reporting (“MDR”) status (as required by the U.S. Food and Drug Administration (FDA) Regulation 21 CFR Part 803) or need for Vigilance reporting (“Vigilance”) as required by the European Union In Vitro Diagnostic Directive (“IVDD”) or the Canadian Medical Device Regulations (“CMDR”).

• Under the terms of such subcontracting relationship (the “Biomarker Agreement”), OV shall retain worldwide commercialization rights to the DRP Biomarker in the Field, including but not limited to use of the DRP Biomarker as an In Vitro Diagnostic (IVD) medical device and/or as a Laboratory Developed Test (LDT) diagnostic.

More Definitions of In Vitro Diagnostic

In Vitro Diagnostic means: (i) in the United States, an Assay intended for use in the disease prognosis or treatment selection / prediction, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, as more fully defined in 21 C.F.R. § 800 et seq., including so-called complementary diagnostics (e.g., those used to identify patients whose Biomarker status is associated with a changed therapeutic response), companion diagnostics for a pharmaceutical product as defined in FDA’s “Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices”, (ii) in the European Union, an in vitro diagnostic medical device as defined in the European directive 98/79/EC, and (iii) any similar definitions set by Regulatory Authorities in Markets outside of the United States and the European Union.

In Vitro Diagnostic means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, which requires Regulatory Approval prior to commercial use, excluding approval required under the Clinical Laboratory Improvement Amendments ("CLIA“). This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles.

In Vitro Diagnostic means [**]. 1.142 “Japan Regulatory Approval” means [**]. 1.143 “Joint Inventions” shall have the meaning set forth in Section 10.1(a). 1.144 “Joint Patents” shall have the meaning set forth in Section 10.1(a). 1.145 “JSC” shall have the meaning set forth in Section 3.2(a). 1.146 “Know-How” means any and all commercial, technical, scientific and other types of (a) data (including datasets), documents, information, conclusions, inventions (whether patentable or not), discoveries, know-how, technology, protocols, assays, methods, processes, formulae, instructions, techniques, designs, drawings or specifications (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, preclinical, clinical, safety, manufacturing and quality control data and information); and (

In Vitro Diagnostic means those reagents, instruments and systems intended for use in the diagnosis of disease or other conditions, including the state of health, in order to cure, mitigate, treat, or prevent or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.