primary sample collection device

apparatus specifically intended by an IVD manufacturer to obtain, contain and preserve a body fluid or tissue for in vitro diagnostic examination

Note 1

Includes devices intended to store a primary sample prior to examination.

Note 2

Includes both vacuum and non-vacuum primary sample collection devices.

Note 3

Adapted from Reference [38], Article 1, 2(b).

Norm

Titel

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

Paragraaf

3.55