YY/T 0456.1-2003
Replaced
YY/T 1304.2-2015
Active
Industry standards-Medicine
YY/T 1304.2-2015 Detection system of time-resolved fluoroimmunoassay—Part 2:Quantitative reagent(kit) for time-resolved fluoroimmunoassay
YY/T 1304.2-2015 Detection system of time-resolved fluoroimmunoassay—Part 2:Quantitative reagent(kit) for time-resolved fluoroimmunoassay
Basic Information
Standard Code:
YY/T 1304.2-2015
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2015-03-02
Implement Date:
2016-01-01
Pages:
7 pages
Scope
This part of YY/T 1304 specifies the terms and definitions, requirements, and test methods for time-resolved fluorescence immunoassay quantitative determination reagents (kits) (hereinafter referred to as reagent kits), as well as their marking, labeling, and user manuals, packaging, transportation, and storage.
This part is applicable to single-label time-resolved fluorescence immunoassays.
This part is not applicable to dual-label and multi-label time-resolved fluorescence immunoassays.
Development Information
Same series standard
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 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