YY/T 1585-2024 Active Industry standards-Medicine

YY/T 1585-2024 25-Hydroxyl vitamin D testing kit

YY/T 1585-2024 25-Hydroxyl vitamin D testing kit

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1585-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-10-15

Pages: 16 pages

Scope

This document specifies the requirements, marking, labeling, and user instructions for 25-hydroxy vitamin D assay kits, as well as their packaging, transportation, and storage, and describes the corresponding testing methods.
This document is applicable to the quantitative detection of total 25-hydroxy vitamin D, 25-hydroxy vitamin D2, and 25-hydroxy vitamin D3 in human serum or plasma using assay kits, including labeled immunoassays (such as enzyme-labeled and luminescence-labeled assays), immunoassay chromatography, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry, among others.

Development Information

Word Count: 21 Thousand words Pages: 16 pages

Replace the following standards

YY/T 1585-2017 Total 25-hydroxyl vitamin D testing kit(labelling immunoassay)

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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