component

part of a finished, packaged and labelled IVD medical device

Note 1

Typical kit components include antibody solutions, buffer solutions, calibrators and/or control materials.

Note 2

Adapted from Reference [40], 820.3(c).

Norm

Titel

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

Paragraaf

3.12