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In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions | Status: Current, Project Underway, Superseded
description
1 Scope
This Technical Specification is intended for
- — IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and
- — medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.
- — nucleic acid-based examinations that are not intended for in vitro diagnostic use, or
- — quantitative nucleic acid-based in vitro diagnostic examination procedures.
Details
Publisher
BS
File size
1.21 MB
Pages
34
Format
PDF
Publication date
2014-12-31
ISBN-13
978-0-580-89200-4
ISBN-13 plain
9780580892004
ISBN-10
0580892004
