
Standard Document
First Edition
ISO
ISO21474-3
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 3: Interpretation and reports
This document sets out the general requirements for interpretation and reporting of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.
November 01, 2024
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ISO21474-3E
14