IVD

IVD. Or "in vitro diagnostic" shall mean 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 sequelae, as more fully defined in 21 C.F.R. § 800 et seq.

IVD. 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

IVD. In vitro diagnostic medical device as defined in the US Code of Federal Regulations Title 21, Section 809.3 or the Regulation (EU) 2017/746 of the European Parliament, the European directive 98/79/EC, or any similar definitions set by Governmental Authorities in markets outside of the United States and the European Union. 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 (August 6, 2014) View More