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IVD reagent

chemical, biological or immunological components, solutions or preparations intended by the manufacturer to be used as an IVD medical device

Note 1

Adapted from EN 375:2001, definition 3.9.

Norm
NEN-EN-ISO 18113-1:2011 en
Titel
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Paragraaf
3.28
Terug

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