YY/T 0456.1-2003
Replaced
GB/T 40983-2021
Active
National standards
GB/T 40983-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit
GB/T 40983-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit
Basic Information
Standard Code:
GB/T 40983-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2021-11-26
Implement Date:
2022-03-01
Pages:
9 pages
Scope
This document specifies the quality evaluation requirements, test methods, labels and instructions, packaging, transportation, and storage for the novel coronavirus IgG antibody detection kits. This document is applicable to kits that use the principles of immunoassay, enzyme-linked immunosorbent assay (ELISA), and chemiluminescence to perform in vitro qualitative detection of novel coronavirus-specific IgG antibodies in human serum, plasma, and whole blood.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active