kit

set of components that are packaged together and intended to be used to perform a specific IVD examination

Note 1

Kit components can include reagents (such as antibodies, enzymes, buffer and diluents), calibrators, controls and other articles and materials.

Note 2

Adapted from EN 375:2001, definition 3.10.

Norm

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.32