YY/T 0456.1-2003
Replaced
YY/T 1713-2020
Active
Industry standards-Medicine
YY/T 1713-2020 Diagnostic kit for colloidal gold immunochromatographic assay
YY/T 1713-2020 Diagnostic kit for colloidal gold immunochromatographic assay
Basic Information
Standard Code:
YY/T 1713-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2020-09-27
Implement Date:
2022-06-01
Pages:
20 pages
Scope
This standard specifies the relevant terms and definitions, requirements, test methods, labels and user manuals, packaging, transportation, and storage for colloidal gold immunoassay detection kits.
This standard applies to kits that use the colloidal gold immunoassay method to perform quantitative, semi-quantitative, and qualitative detection of human samples (such as blood, urine, feces, saliva, etc.).
Development Information
Referenced Standards
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
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 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples
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