YY/T 1252-2015 Active Industry standards-Medicine

YY/T 1252-2015 Total IgE quantitative labelling immunoassay kit

YY/T 1252-2015 Total IgE quantitative labelling immunoassay kit

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1252-2015

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: 8 pages

Scope

This standard specifies the quality requirements, testing methods, user manuals, markings, labels, packaging, transportation, and storage for total IgE quantitative marking immunoassay kits.
This standard applies to marking immunoassay kits (hereinafter referred to as kits) used for total IgE quantitative determination. These kits include those using enzyme marking, chemiluminescence marking, and other marking methods for capture antibodies, and using microplates, tubes, magnetic particles, microbeads, and plastic beads as carriers for antibody coating, for quantitative determination of total IgE.

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 YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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