YY/T 0456.1-2003
Replaced
YY/T 1581-2018
Active
Industry standards-Medicine
YY/T 1581-2018 Allergy-specific IgE detection kit
YY/T 1581-2018 Allergy-specific IgE detection kit
Basic Information
Standard Code:
YY/T 1581-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2018-02-24
Implement Date:
2019-03-01
Pages:
11 pages
Scope
This standard specifies the requirements, testing methods, labels, and user manuals, as well as packaging, transportation, and storage for allergen-specific IgE antibody detection kits. This standard applies to kits (hereinafter referred to as "kits") used in medical laboratories to quantitatively/semi-quantitatively/qualitatively detect allergen-specific IgE antibodies in human serum or plasma, based on the principles of enzyme-linked immunosorbent assay (ELISA), chemiluminescence, fluorescence immunoassay, colloidal gold immunoassay, and immunoblotting.
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
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YY/T 0475-2004
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YY/T 0478-2004
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