YY/T 1969-2025 Pending Industry standards-Medicine

YY/T 1969-2025 Microalbumin testing kit(Immunoturbidimetry)

YY/T 1969-2025 Microalbumin testing kit(Immunoturbidimetry)

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 1969-2025

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 requirements, marking, labeling, and user manuals for the microalbumin assay kit (immunoturbidimetry), as well as its packaging, transportation, and storage. It also describes the corresponding testing methods.
This document is applicable to kits used for quantitative detection of albumin in human urine samples by immunoturbidimetry.

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 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements 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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