GB/T 39367.1-2020
GB/T 39367.1-2020 In vitro diagnostic test systems—Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens—Part 1:General requirements,terms and definitions
Abstract
This part of GB/T 39367 is applicable to:
—— Manufacturers of in vitro diagnostic medical devices, medical laboratories, and scientific research laboratories that develop nucleic acid-based qualitative in vitro diagnostic testing procedures for detecting and identifying microbial pathogens in human specimens; and
—— Medical laboratories that conduct nucleic acid-based in vitro diagnostic testing for detecting and identifying microbial pathogens in human specimens.
This part is not applicable to:
—— Nucleic acid tests that are not intended for in vitro diagnosis; or
—— Nucleic acid-based quantitative in vitro diagnostic testing procedures.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Replaced |
| Standard Code | GB/T 39367.1-2020 |
| CCS | Medical devices |
| ICS | Experiment (vocabulary) |
| Implement Date | 2022-06-01 |