Diagnostic Field

Diagnostic Field. In vitro testing for research use, or exploratory use, or as a clinical diagnostic for use in the diagnosis and/or ongoing evaluation of a human disease or medical condition, including the prediction and/or monitoring of a response to a therapeutic agent, and also use as an IVD.

Diagnostic Field. Means the in vitro measurement, monitoring, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being, in all cases in order to diagnose, medically manage, cure, mitigate, treat or prevent disease of the human being from which the specimen(s) was (were) taken.