IVD definition

IVD means in vitro diagnostic.

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 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

• The permittee shall modify the plan whenever necessary to address any of the triggering conditions for corrective action in Part IV.D and to ensure that they do not reoccur, or to reflect changes implemented when a review following the triggering conditions in Part IV.D.2 indicates that changes to your control measures are necessary to meet the control measures/best management practices (BMPs) in this permit.

• Any corrective action required as a result of a quarterly visual assessment shall be performed consistent with Part IV.D of this permit.

• A majority of the Independent Directors must approve any Board action to which the following sections of the NASAA REIT Guidelines apply: II.A., II.C., II.F., II.G., IV.A., IV.B., IV.C., IV.D., IV.E., IV.F., IV.G., V.E., V.H., V.J., VI.A., VI.B.4, and VI.G.

• The disclosure of your Social Security number is mandatory on all professional and occupational license applications, is solicited by the authority granted by 42 U.S.C. §§ 653 and 654, and will be used by the Department of Business and Professional Regulation pursuant to §§ 409.2577, 409.2598, 455.203(9), and 559.79(3), Florida Statutes, for the efficient screening of applicants and licensees by a Title IV-D child support agency to assure compliance with child support obligations.

• Section IV.D of the FOA provides instructions on submitting a Full Application.

More Definitions of IVD

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 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 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 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 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 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 means in vitro diagnostics.