YY/T 1456-2016 Active Industry standards-Medicine

YY/T 1456-2016 Human ferritin quantitative test reagent

YY/T 1456-2016 Human ferritin quantitative test reagent

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1456-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 8 pages

Scope

This standard specifies the requirements for ferritin quantitative detection reagents (kits), testing methods, and markings, labels, user manuals, packaging, transportation, and storage, etc.
This standard applies to reagents (kits) used for quantitatively detecting ferritin in blood or urine samples based on the principle of antigen-antibody reaction (hereinafter referred to as "Ferr-reagents (kits)"). The reagent kit methods include quantitative labeled immunoassays (such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro) chemiluminescence, etc.) and immunoturbidimetry (such as immunoturbidimetry, latex-enhanced immunoturbidimetry, etc.).
This standard does not apply to the evaluation of ferritin calibrators and quality control materials.

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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