The Medical Devices Introductory Course 2020

What are IVD’s

• IVD’s are “In-Vitro Diagnostics”. Literal “in-glass” tests and the name is derived from Latin. • Radio Immunoassay first outlined by Berson and Yallow in 1960 for Plasma Insulin (Nobel Prize) • ELISA/EIA were developed by Engvall and Perlmann (IgG)/van Weemen and Schuurs (Hcg) who both published in 1971. • Monoclonal antibodies discovered in 1975 by Kohler, Milstein and Kaj Jerne. (Nobel Prize) • Early 1980’s first Immunoassay instruments by Bohringer and Abbott

The Organisation for Professionals in Regulatory Affairs

How a blood sample is tested in a hospital today

IVD

IVD

IVD

The Organisation for Professionals in Regulatory Affairs