In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids-Terminology and general requirements for nucleic acid quality evaluation

Publisher:
British Standard / International Organization for Standardization

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular 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.

All current amendments available at time of purchase are included with the purchase of this document.

File Size :	1 file , 1.4 MB
ISBN(s) :	9780580986567
Note :	This product is unavailable in Russia, Ukraine, Belarus
Number of Pages :	32
Product Code(s) :	30361174, 30361174, 30361174
Published :	08/24/2020
Same As :	BS ISO 21474-1:2020

BS ISO 21474-1:2020 PDF

In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids-Terminology and general requirements for nucleic acid quality evaluation

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