IVD definition

IVD means in vitro diagnostic.

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IVD. (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;

IVD means in vitro diagnostic medical device as defined in the European directive 98/79/EC; for the avoidance of doubt the term IVD includes companion diagnostics for a pharmaceutical product as defined in FDA’s “Guidance for Industry and Food and Drug Administration Staff—In Vitro Companion Diagnostic Devices” dated August 6, 2014.

Examples of IVD in a sentence

• Unless the Company disputes that it is in noncompliance with the minimum employment levels in Sections IV.C and IV.D, the Company acknowledges and agrees that any right to an administrative hearing pursuant to the Illinois Administrative Procedure Act, 5 ILCS 100/1-1, et seq.

• An automatic suspension will be lifted upon a showing by the Company that it has returned to compliance with the minimum employment levels in Sections IV.C and IV.D, and the Department shall notify the Illinois Department of Revenue of the lifting of an automatic suspension.

• Pursuant to Section 211(4) of the Illinois Income Tax Act, the Company may carryforward any Unused Credit and apply it to its Illinois State Income Taxes imposed in the five (5) Taxable Years following the Taxable Year in which there is Unused Credit so long as the Company is in compliance with the terms and conditions of this Agreement, and subject to the limitations on the total amount of Credits for all Taxable Years, as set forth in Sections IV.B through IV.D.

• The Project shall be Placed in Service by the Company, and the requirements of Sections IV.B through IV.D shall be met, by the Benchmark Date.

• The Credit is eligible for issuance in ten (10) consecutive Taxable Years, beginning with the earlier of the Taxable Year for which the Company applies for and is issued the Credit in accordance with Section VI.A of this Agreement or the Taxable Year containing the Benchmark Date (even if the Company has not achieved its commitments in Sections IV.B through IV.D).

More Definitions of IVD

IVD or “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.

IVD or “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.

IVD or “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.

IVD means an in vitro diagnostic product (as defined in § 809.3(a) of the FD&C Act or under comparable regulation in jurisdictions outside the United States) and which is intended for use to predict disease prognosis and/or the safety or efficacy of therapeutic treatment.

IVD means a medical device as defined in section 210(h) of the FD&C Act, and may also be a biological product subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket clearance or approval by FDA as well as postmarket controls. Premarket clearance pursuant to the 510 (k) process applies to IVDs that are substantially equivalent to an existing predicate device and the premarket approval process applies to IVDs for which no predicate device exists. IVDs are also subject to the Clinical Laboratory Improvement Amendments of 1988. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]

IVD means an In vitro diagnostics test on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

IVD means any in vitro diagnostic product and those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, including the collection, preparation and examination of specimens taken from the human body.