YY/T 1513-2017 Active Industry standards-Medicine

YY/T 1513-2017 C-reactive protein testing kit

YY/T 1513-2017 C-reactive protein testing kit

Publish Date: 2017-03-28 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1513-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2017-03-28

Implement Date: 2018-04-01

Pages: 8 pages

Scope

This standard specifies the classification, requirements, testing methods, and marking, labeling, user manuals, packaging, transportation, and storage of C-reactive protein assay kits.
This standard applies to assay kits for quantitatively measuring C-reactive protein in blood samples based on the principle of antigen-antibody reaction (hereinafter referred to as CRP assay kits), including quantitative labeled immunoassays [such as (electro) chemiluminescence] and immunoturbidimetry (such as immunoturbidimetry and latex-enhanced immunoturbidimetry).
This standard does not apply to:
a) The evaluation of C-reactive protein calibrators and quality control materials.
b) Various colloidal gold-labeled test strips.

Development Information

Word Count: 14 Thousand words Pages: 8 pages

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 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 GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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