GB/T 40983-2021
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgG antibody detection kit (English Version)

Standard No.

GB/T 40983-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 40983-2021

Scope

This document specifies the quality evaluation requirements, test methods, labels and instructions, packaging, transportation and storage of the new coronavirus IgG antibody detection kit. This document is applicable to kits for in vitro qualitative detection of novel coronavirus-specific IgG antibodies in human serum, plasma and whole blood using the principles of immunochromatography, enzyme-linked immunoassay and chemiluminescence.

GB/T 40983-2021 Referenced Document

• GB/T 191 Packaging.Pictorial marking for handling of goods
• GB/T 29791.2 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use

GB/T 40983-2021 history

• 2021 GB/T 40983-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgG antibody detection kit