YY/T 1958-2025 Pending Industry standards-Medicine

YY/T 1958-2025 17α-Hydroxyprogesterone testing kit(Labelling immunoassay)

YY/T 1958-2025 17α-Hydroxyprogesterone testing kit(Labelling immunoassay)

Publish Date: 2025-06-18 Implement Date: 2026-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1958-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2025-06-18

Implement Date: 2026-07-01

Pages: 12 pages

Scope

This document specifies the technical requirements, marking, labeling, and usage instructions, packaging, transportation, and storage for the 17-alpha-hydroxyprogesterone assay kit (marked immunoassay), and describes the corresponding testing methods.
This document is applicable to immunoassay kits used for the quantitative determination of 17-alpha-hydroxyprogesterone in human serum, plasma, and heel prick blood (dried blood spots on filter paper) by methods such as enzyme marking, (electro)chemiluminescence marking, and (time-resolved) fluorescence marking.
This document is not applicable to:
a) immunoassay kits for immunochromatography;
b) calibrators and quality control products intended for separate sale.

Development Information

Word Count: 13 Thousand words Pages: 12 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 191-2025 Graphical symbols marking for handling and storage of packages 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 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 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use

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