YY/T 1422-2016 Active Industry standards-Medicine

YY/T 1422-2016 Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)

YY/T 1422-2016 Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)

Publish Date: 2016-07-29 Implement Date: 2017-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1422-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2016-07-29

Implement Date: 2017-06-01

Pages: 8 pages

Scope

This standard specifies the requirements, test methods, and labeling, instructions for use, packaging, transportation, and storage for serum pregnancy-associated plasma protein A detection reagents (kits) (quantitative labeled immunoassay).
This standard applies to quantitative detection reagents (kits) for serum pregnancy-associated plasma protein A (quantitative labeled immunoassay) [hereinafter referred to as PAPP-A reagents (kits)]. Quantitative labeled immunoassays include: enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, and (electro)chemiluminescence, etc.

Development Information

Word Count: 14 Thousand words Pages: 8 pages

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 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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