YY/T 0456.1-2003
Replaced
YY/T 1831-2021
Active
Industry standards-Medicine
YY/T 1831-2021 Treponema pallidum antibodies detection kit (immunochromatographic method)
YY/T 1831-2021 Treponema pallidum antibodies detection kit (immunochromatographic method)
Basic Information
Standard Code:
YY/T 1831-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2021-12-06
Implement Date:
2023-05-01
Pages:
7 pages
Scope
This document specifies the requirements, test methods, markings, labels, and user manuals for syphilis spirochete antibody detection kits (immunochromatography), as well as their packaging, transportation, and storage.
This document applies to syphilis spirochete antibody detection kits, such as colloidal gold and latex methods, which use immunochromatography as the principle to perform qualitative determination of syphilis spirochete antibodies in human serum, plasma, or 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