GB/T 40966-2021
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit (English Version)
- Standard No.
- GB/T 40966-2021
- 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 40966-2021
- Scope
- This document gives the quality evaluation requirements, test methods, labels and instructions, packaging, transportation and storage of the novel coronavirus antigen detection kit. This document applies to upper respiratory tract samples such as throat swabs, nasal swabs, saliva, blood samples such as serum, plasma and whole blood, and lower respiratory tract samples such as sputum, respiratory tract extracts, bronchial lavage fluid, and alveolar lavage fluid. Quality evaluation of novel coronavirus antigen detection kits for testing samples.
GB/T 40966-2021 Referenced Document
- GB/T 191 Packaging.Pictorial marking for handling of goods
- GB/T 29791.1 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
- 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 40966-2021 history
- 2021 GB/T 40966-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit
